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

Completed

• Conditions: SARS CoV 2 Infection; Hypoxemic Respiratory Failure

• Registration Number: NCT04995289
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-31
• Status Verified: 2021-08
• Study First Posted: 2021-08-06
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
amelioration of PaO2/FiO2	through study completion, an average of 1 yea	the investigators recoordeed Blood gas analysis before and after Prone position

Trial Locations

Locations (1)

younes Oujidi; 🇲🇦 Berkane, Morocco