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Continuous Evaluation of Diaphragm Function

Primary Purpose

Respiration, Artificial, Mechanical Ventilation, Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Assesment of diaphragm function
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiration, Artificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
  • Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
  • Pressure support level between 4 and 10 cmH2O
  • Ratio between PaO2 and FiO2 >200 mmHg
  • Resolution of the cause of respiratory failure

Exclusion Criteria:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Pregnancy
  • Circulatory failure

Sites / Locations

  • Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e CarloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Clinical pressure support

Reduced pressure support

Lowest pressure support

Arm Description

The level of inspiratory pressure support will be selected by the attending physician

The level of inspiratory pressure support will be reduced by 25%

The level of inspiratory pressure support will be reduced by 50%

Outcomes

Primary Outcome Measures

Diaprhagm excursion
Excursion (in mm) between expiration and inspiration

Secondary Outcome Measures

Esophageal pressure swing
Difference (in cmH2O) in esophageal pressure between expiration and inspiration
Pressure-time product
Integral of the area under the esophageal pressure over time (in cmH2O*sec)
Pressure-time product
Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec)

Full Information

First Posted
May 3, 2019
Last Updated
November 3, 2020
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT03941002
Brief Title
Continuous Evaluation of Diaphragm Function
Official Title
Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction" Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement. A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators. In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims: to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP) to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Mechanical Ventilation, Critical Illness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical pressure support
Arm Type
Placebo Comparator
Arm Description
The level of inspiratory pressure support will be selected by the attending physician
Arm Title
Reduced pressure support
Arm Type
Active Comparator
Arm Description
The level of inspiratory pressure support will be reduced by 25%
Arm Title
Lowest pressure support
Arm Type
Active Comparator
Arm Description
The level of inspiratory pressure support will be reduced by 50%
Intervention Type
Diagnostic Test
Intervention Name(s)
Assesment of diaphragm function
Intervention Description
Diaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation
Primary Outcome Measure Information:
Title
Diaprhagm excursion
Description
Excursion (in mm) between expiration and inspiration
Time Frame
Study 1 day
Secondary Outcome Measure Information:
Title
Esophageal pressure swing
Description
Difference (in cmH2O) in esophageal pressure between expiration and inspiration
Time Frame
Study 1 day
Title
Pressure-time product
Description
Integral of the area under the esophageal pressure over time (in cmH2O*sec)
Time Frame
Study 1 day
Title
Pressure-time product
Description
Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec)
Time Frame
Study 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode. Positive end-expiratory pressure (PEEP) lower than 10 cmH2O Pressure support level between 4 and 10 cmH2O Ratio between PaO2 and FiO2 >200 mmHg Resolution of the cause of respiratory failure Exclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Pregnancy Circulatory failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Chiumello
Phone
+390281844476
Email
davide.chiumello@unimi.it
Facility Information:
Facility Name
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Chiumello
Phone
+390281844020
Email
chiumello@libero.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Continuous Evaluation of Diaphragm Function

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