Diaphragm Dysfunction in ARDS Patients With V-V ECMO

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: diaphragmatic function measurements and diaphragmatic ultrasound

• Registration Number: NCT04613752
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2021-02-15
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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)"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	diaphragmatic function measurements and diaphragmatic ultrasound	A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.

Primary Outcome Measures

Name	Time	Method
Diaphragm function	until day 28	as defined by the pressure generating capacity of the diaphragm \< 11 cmH2O

Secondary Outcome Measures

Name	Time	Method
Duration of ECMO	until day 60	from inclusion until ECMO removal
Duration of invasive mechanical ventilation	until day 60	from inclusion until extubation

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, Ile De France, France