Diaphragm Dysfunction in ARDS Patients With V-V ECMO

NCT ID: NCT04613752

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-10-15

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

diaphragmatic function measurements and diaphragmatic ultrasound

Intervention Type: DEVICE

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

Interventions

diaphragmatic function measurements and diaphragmatic ultrasound

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

Intervention Type: DEVICE

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)"

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Dres

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France

Countries

France

References

Gautier M, Joussellin V, Ropers J, El Houari L, Demoule A, Similowski T, Combes A, Schmidt M, Dres M. Diaphragm function in patients with Covid-19-related acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation. Ann Intensive Care. 2023 Sep 26;13(1):92. doi: 10.1186/s13613-023-01179-w.

Reference Type: DERIVED

PMID: 37752337 (View on PubMed)

Other Identifiers

APHP190988

Identifier Type: -

Identifier Source: org_study_id