Back to resultsDiaphragm Dysfunction in ARDS Patients With V-V ECMO (DD-ECMO)
Primary Purpose
Respiratory Distress Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diaphragmatic function measurements and diaphragmatic ultrasound
Sponsored by
About this trial
This is an interventional other trial for Respiratory Distress Syndrome focused on measuring ARDS, ECMO, diaphragm function
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- ARDS according to the Berlin definition
- V-V ECMO
- patient or next of kin agrees to participate
- patient with health insurance
Exclusion Criteria:
- pregnancy
- Opposition to participate
- Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"
Sites / Locations
- Hôpital Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
Outcomes
Primary Outcome Measures
Diaphragm function
as defined by the pressure generating capacity of the diaphragm < 11 cmH2O
Secondary Outcome Measures
Duration of ECMO
from inclusion until ECMO removal
Duration of invasive mechanical ventilation
from inclusion until extubation
Full Information
NCT ID
NCT04613752
First Posted
October 15, 2020
Last Updated
June 14, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04613752
Brief Title
Diaphragm Dysfunction in ARDS Patients With V-V ECMO
Acronym
DD-ECMO
Official Title
Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
No more Covid patients in the service and number of patients included sufficient for stastistical analysis.
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.
Detailed Description
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
ARDS, ECMO, diaphragm function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
Intervention Type
Device
Intervention Name(s)
diaphragmatic function measurements and diaphragmatic ultrasound
Intervention Description
A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
Primary Outcome Measure Information:
Title
Diaphragm function
Description
as defined by the pressure generating capacity of the diaphragm < 11 cmH2O
Time Frame
until day 28
Secondary Outcome Measure Information:
Title
Duration of ECMO
Description
from inclusion until ECMO removal
Time Frame
until day 60
Title
Duration of invasive mechanical ventilation
Description
from inclusion until extubation
Time Frame
until day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
ARDS according to the Berlin definition
V-V ECMO
patient or next of kin agrees to participate
patient with health insurance
Exclusion Criteria:
pregnancy
Opposition to participate
Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dres
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diaphragm Dysfunction in ARDS Patients With V-V ECMO
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