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
About this trial
This is an interventional diagnostic trial for Respiration, Artificial
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
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
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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