Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation (VIREM)
Primary Purpose
Respiratory Muscles, Respiration, Artificial, Respiratory Function Tests
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Placement of nasogastric balloon
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Muscles
Eligibility Criteria
Inclusion Criteria:
- age > 28 days
- weight > 3kg
- requiring invasive mechanical ventilation
- anticipated length of ventilation > 48h
Exclusion Criteria:
- refusal of consent
- mechanical ventilation ≤ 2 weeks before inclusion
- known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
- contra-indication to the placement of a naso-gastric esophageal balloon catheter
Sites / Locations
- Antwerp University Hospital (UZA)Recruiting
- University Hospital Leuven (UZL)
- The Hospital for Sick Children (SickKids)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overall group
Arm Description
Placement of a nasogastric balloon
Outcomes
Primary Outcome Measures
Tidal esophageal pressure swing (∆Pes) - D1
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D2
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D3
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D4
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D5
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D6
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D7
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D8
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Secondary Outcome Measures
Transpulmonary driving pressure (ΔPL) - D1
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D2
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D3
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D4
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D5
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D6
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D7
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D8
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Occlusion pressure (P0.1) - D1
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D2
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D3
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D4
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D5
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D6
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D7
P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D8
P0.1 is measured during the first 100 milliseconds of a breath
End-expiratory diaphragm thickness (DTee) - D1
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D2
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D3
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D4
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D5
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D6
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D7
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D8
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D1
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D2
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D3
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D4
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D5
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D6
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D7
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D8
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Duration of mechanical ventilation
Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)
Maximal inspiratory pressure (MIP) - D1
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D2
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D3
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D4
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D5
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D6
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D7
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D8
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Need for tracheal reintubation after tracheal extubation
Lung ultrasound scores (LUSS) - D1
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D2
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D3
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D4
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D5
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D6
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D7
Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D8
Measured once daily for the first 8 days of mechanical ventilation
ICU length of stay
Duration to live discharge from the ICU
ICU mortality
Hospital length of stay
Duration to live discharge from hospital
Duration to decease
Cumulative time to death counting from the day of intubation
Hospital mortality
Presence of clinical signs of muscle weakness at ICU discharge
Presence of clinical signs of muscle weakness at hospital discharge
ICU readmission rate within 48 hours
Inspiratory muscle pressure (Pmus) - D1
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D2
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D3
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D4
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D5
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D6
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D7
Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D8
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D1
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D2
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D3
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D4
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D5
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D6
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D7
Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D8
Measured at least once daily for the first 8 days of mechanical ventilation
Esophageal pressure-time product (PTPes) - D1
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D2
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D3
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D4
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D5
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D6
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D7
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D8
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D1
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D2
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D3
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D4
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D5
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D6
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D7
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D8
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Full Information
NCT ID
NCT05459116
First Posted
June 28, 2022
Last Updated
September 22, 2022
Sponsor
University Hospital, Antwerp
Collaborators
Research Foundation Flanders, Universitaire Ziekenhuizen KU Leuven, The Hospital for Sick Children, University of Toronto, Universiteit Antwerpen, KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05459116
Brief Title
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
Acronym
VIREM
Official Title
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Research Foundation Flanders, Universitaire Ziekenhuizen KU Leuven, The Hospital for Sick Children, University of Toronto, Universiteit Antwerpen, KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Muscles, Respiration, Artificial, Respiratory Function Tests
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Overall group
Arm Type
Experimental
Arm Description
Placement of a nasogastric balloon
Intervention Type
Device
Intervention Name(s)
Placement of nasogastric balloon
Intervention Description
A nasogastric balloon catheter will be inserted after inclusion. This will be a NutriVent (Sidam S.R.L., Mirandola, Italy) for patients >40kg, and a SmartCath Esophageal pressure catheter (Vyaire/Carefusion) for patients <40kg. This placement is similar to a standard nasogastric tube placement, which is a common procedure in an ICU. Potential minor side effects include a nosebleed, sore throat and erosion of the nose where the tube is anchored. All patients will receive this intervention. When the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.
Primary Outcome Measure Information:
Title
Tidal esophageal pressure swing (∆Pes) - D1
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D2
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D3
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D4
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D5
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D6
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D7
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation
Title
Tidal esophageal pressure swing (∆Pes) - D8
Description
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Time Frame
∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Secondary Outcome Measure Information:
Title
Transpulmonary driving pressure (ΔPL) - D1
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D2
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D3
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D4
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 4 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D5
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 5 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D6
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 6 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D7
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
Title
Transpulmonary driving pressure (ΔPL) - D8
Description
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time Frame
∆PL (average over 1 minute recording) at day 8 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D1
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D2
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D3
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D4
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D5
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D6
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D7
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
Title
Occlusion pressure (P0.1) - D8
Description
P0.1 is measured during the first 100 milliseconds of a breath
Time Frame
P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D1
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 1 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D2
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 2 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D3
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 3 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D4
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 4 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D5
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 5 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D6
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 6 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D7
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 7 of mechanical ventilation
Title
End-expiratory diaphragm thickness (DTee) - D8
Description
Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTee (average of 3 breaths) at day 8 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D1
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 1 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D2
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 2 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D3
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 3 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D4
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 4 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D5
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 5 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D6
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 6 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D7
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 7 of mechanical ventilation
Title
Diaphragm thickening fraction (DTF) measured with ultrasound - D8
Description
DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.
The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Time Frame
DTF (average of 3 breaths) at day 8 of mechanical ventilation
Title
Duration of mechanical ventilation
Description
Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)
Time Frame
From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months
Title
Maximal inspiratory pressure (MIP) - D1
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 1 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D2
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 2 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D3
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 3 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D4
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 4 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D5
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 5 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D6
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 6 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D7
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 7 of mechanical ventilation
Title
Maximal inspiratory pressure (MIP) - D8
Description
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time Frame
MIP at day 8 of mechanical ventilation
Title
Need for tracheal reintubation after tracheal extubation
Time Frame
From date of inclusion until the date of reintubation or date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months.
Title
Lung ultrasound scores (LUSS) - D1
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 1 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D2
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 2 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D3
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 3 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D4
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 4 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D5
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 5 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D6
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 6 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D7
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 7 of mechanical ventilation
Title
Lung ultrasound scores (LUSS) - D8
Description
Measured once daily for the first 8 days of mechanical ventilation
Time Frame
LUSS at day 8 of mechanical ventilation
Title
ICU length of stay
Description
Duration to live discharge from the ICU
Time Frame
From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
ICU mortality
Time Frame
From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
Hospital length of stay
Description
Duration to live discharge from hospital
Time Frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
Duration to decease
Description
Cumulative time to death counting from the day of intubation
Time Frame
From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Title
Hospital mortality
Time Frame
From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
Presence of clinical signs of muscle weakness at ICU discharge
Time Frame
From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
Presence of clinical signs of muscle weakness at hospital discharge
Time Frame
From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
ICU readmission rate within 48 hours
Time Frame
From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Title
Inspiratory muscle pressure (Pmus) - D1
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 1 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D2
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 2 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D3
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 3 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D4
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 4 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D5
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 5 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D6
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 6 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D7
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 7 of mechanical ventilation
Title
Inspiratory muscle pressure (Pmus) - D8
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
Pmus at day 8 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D1
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 1 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D2
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 2 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D3
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 3 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D4
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 4 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D5
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 5 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D6
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 6 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D7
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 7 of mechanical ventilation
Title
Occlusion pressure (∆Pocc) - D8
Description
Measured at least once daily for the first 8 days of mechanical ventilation
Time Frame
∆Pocc at day 8 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D1
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 1 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D2
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 2 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D3
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 3 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D4
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 4 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D5
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 5 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D6
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 6 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D7
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 7 of mechanical ventilation
Title
Esophageal pressure-time product (PTPes) - D8
Description
Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
PTPes at day 8 of mechanical ventilation
Title
Dead space ventilation (VD) - D1
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 1 of mechanical ventilation
Title
Dead space ventilation (VD) - D2
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 2 of mechanical ventilation
Title
Dead space ventilation (VD) - D3
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 3 of mechanical ventilation
Title
Dead space ventilation (VD) - D4
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 4 of mechanical ventilation
Title
Dead space ventilation (VD) - D5
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 5 of mechanical ventilation
Title
Dead space ventilation (VD) - D6
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 6 of mechanical ventilation
Title
Dead space ventilation (VD) - D7
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 7 of mechanical ventilation
Title
Dead space ventilation (VD) - D8
Description
Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Time Frame
VD at day 8 of mechanical ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 28 days
weight > 3kg
requiring invasive mechanical ventilation
anticipated length of ventilation > 48h
Exclusion Criteria:
refusal of consent
mechanical ventilation ≤ 2 weeks before inclusion
known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
contra-indication to the placement of a naso-gastric esophageal balloon catheter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vertongen
Phone
+323 821 44 04
Email
icu-research@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marquez
Phone
+323 821 36 35
Email
inzo@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Schepens, M.D., Ph.D.
Organizational Affiliation
PICU staff member
Official's Role
Study Director
Facility Information:
Facility Name
Antwerp University Hospital (UZA)
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vertongen
Phone
+323 821 44 04
Email
icu-research@uza.be
First Name & Middle Initial & Last Name & Degree
Tom Schepens, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Philippe G Jorens, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Gregory R De Meyer, M.D.
Facility Name
University Hospital Leuven (UZL)
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Van Maercke
Email
francesca.vanmaercke@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Greet Hermans, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Lars Desmet, M.D.
Facility Name
The Hospital for Sick Children (SickKids)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ta
Email
eva.ta@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Gail Annich, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
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