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Diaphragm Dysfunction in ARDS Patients With V-V ECMO (DD-ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613752
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : February 15, 2021
Estimated Primary Completion Date : July 5, 2022
Estimated Study Completion Date : July 5, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Diaphragm function [ Time Frame: until day 28 ]
    as defined by the pressure generating capacity of the diaphragm < 11 cmH2O


Secondary Outcome Measures :
  1. Duration of ECMO [ Time Frame: until day 60 ]
    from inclusion until ECMO removal

  2. Duration of invasive mechanical ventilation [ Time Frame: until day 60 ]
    from inclusion until extubation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613752


Contacts
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Contact: Martin Dres 33142167809 martin.dres@aphp.fr

Locations
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France
Hôpital Pitié-Salpêtrière Recruiting
Paris, Ile De France, France, 75013
Contact: Martin Dres, MCU-PH    0142167761    martin.dres@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Martin Dres Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04613752    
Other Study ID Numbers: APHP190988
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases