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Diaphragm Dysfunction in ARDS Patients With V-V ECMO

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04613752
Acronym
DD-ECMO
Enrollment
63
Registered
2020-11-03
Start date
2021-02-15
Completion date
2021-10-15
Last updated
2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

ARDS, ECMO, diaphragm function

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.

Interventions

DEVICEdiaphragmatic function measurements and diaphragmatic ultrasound

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm functionuntil day 28as defined by the pressure generating capacity of the diaphragm \< 11 cmH2O

Secondary

MeasureTime frameDescription
Duration of ECMOuntil day 60from inclusion until ECMO removal
Duration of invasive mechanical ventilationuntil day 60from inclusion until extubation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026