DD-ECMO: Diaphragm Dysfunction in ARDS Patients With V-V ECMO

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04613752
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 7.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Device: diaphragmatic function measurements and diaphragmatic ultrasound	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
• Actual Study Start Date: Feb 15, 2021
• Actual Primary Completion Date: Oct 15, 2021
• Actual Study Completion Date: Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.	Device: diaphragmatic function measurements and diaphragmatic ultrasound; A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.

Outcome Measures

Primary Outcome Measures

1. Diaphragm function [until day 28]

   as defined by the pressure generating capacity of the diaphragm < 11 cmH2O

Secondary Outcome Measures

1. Duration of ECMO [until day 60]

   from inclusion until ECMO removal

2. Duration of invasive mechanical ventilation [until day 60]

   from inclusion until extubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Pitié-Salpêtrière	Paris	Ile De France	France	75013

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Study Chair: Martin Dres, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04613752
• Other Study ID Numbers: APHP190988
• First Posted: Nov 3, 2020
• Last Update Posted: Jun 15, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: ARDS; ECMO; diaphragm function
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome

Study Results

No Results Posted as of Jun 15, 2022