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

• Sponsor: Mohammed VI University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04995289
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jan 1, 2020
• Actual Primary Completion Date: Jan 30, 2021
• Actual Study Completion Date: Jan 30, 2021

Outcome Measures

Primary Outcome Measures

1. amelioration of PaO2/FiO2 [through study completion, an average of 1 yea]

   the investigators recoordeed Blood gas analysis before and after Prone position

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	younes Oujidi	Berkane		Morocco	9999

Sponsors and Collaborators

• Mohammed VI University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Younes Oujidi, Principal Investigator, Mohammed VI University Hospital
• ClinicalTrials.gov Identifier: NCT04995289
• Other Study ID Numbers: MohammedVIUH
• First Posted: Aug 6, 2021
• Last Update Posted: Aug 13, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Younes Oujidi, Principal Investigator, Mohammed VI University Hospital: ECMO; ARDS; Prone position; COVID; compliance
• Additional relevant MeSH terms: COVID-19; Respiratory Insufficiency

Study Results

No Results Posted as of Aug 13, 2021