Diaphragm Dysfunction in ARDS Patients With V-V ECMO

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: diaphragmatic function measurements and diaphragmatic ultrasound


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed. | Device: diaphragmatic function measurements and diaphragmatic ultrasound<br>* A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm function | as defined by the pressure generating capacity of the diaphragm < 11 cmH2O | until day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ECMO | from inclusion until ECMO removal | until day 60 | 
| Duration of invasive mechanical ventilation | from inclusion until extubation | until day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, ECMO, diaphragm function