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Prone Position During ECMO in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Hypoxaemic Patient

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ClinicalTrials.gov Identifier: NCT04995289
Recruitment Status : Completed
First Posted : August 6, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Younes Oujidi, Mohammed VI University Hospital

Brief Summary:

Introduction:

The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. One possible therapeutic procedure for these patients is the application of the prone position.

Objective:

The main aim of this study was to investigate the modification of the PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO with refractory hypoxemia. The secondary objective was to evaluate the safety and feasibility of the inclined position for ECMO.

Methods:

the investigators reviewed the electronic records and lists of all 23 COVID-19 patients. were placed for the first time in PP with an average duration of 16 h . patient characteristics, pre-ECMO characteristics, ventilator/ECMO settings, and changes in ventilator/ECMO settings and blood gas analysis before and after PP.


Condition or disease Intervention/treatment
SARS CoV 2 Infection Hypoxemic Respiratory Failure Other: Prone position on ECMO patient

Detailed Description:

The main objective of the current study was to investigate the change in PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO patients with persistent hypoxemia. Measurements were taken before PP, 1 h after the start of the PP, at the end of the PP cycle.

The secondary objective of this study was to assess the safety and feasibility of emergency positioning for patients with severe ARDS during ECMO treatment.

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Prone position on ECMO patient
    blood gas analysis before and after PP


Primary Outcome Measures :
  1. amelioration of PaO2/FiO2 [ Time Frame: through study completion, an average of 1 yea ]
    the investigators recoordeed Blood gas analysis before and after Prone position



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
23 patients admitted to the intensive care unit of different genders and ethnicities were included.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of SARS COV 2 infection complicated by ARDS, and needed a VV ECMO.
  • patient who presented refractory hypoxemia during VV ECMO.

Exclusion Criteria:

  • patient who has received ECMO V-A or ECMO VV for reasons other than ARDS.

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): NCT04995289


Locations
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Morocco
younes Oujidi
Berkane, Morocco, 9999
Sponsors and Collaborators
Mohammed VI University Hospital
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Responsible Party: Younes Oujidi, Principal Investigator, Mohammed VI University Hospital
ClinicalTrials.gov Identifier: NCT04995289    
Other Study ID Numbers: MohammedVIUH
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 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 Younes Oujidi, Mohammed VI University Hospital:
ECMO
ARDS
Prone position
COVID
compliance
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders