Diaphragm Dysfunction in ARDS Patients With V-V ECMO

Respiratory Distress Syndrome Clinical Trial

— DD-ECMO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04613752
• Other study ID #: APHP190988
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: May 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)"

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm function	as defined by the pressure generating capacity of the diaphragm < 11 cmH2O	until day 28
Secondary	Duration of ECMO	from inclusion until ECMO removal	until day 60
Secondary	Duration of invasive mechanical ventilation	from inclusion until extubation	until day 60