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

SARS CoV 2 Infection Clinical Trial

Official title:

Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995289
• Other study ID #: MohammedVIUH
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: August 2021
• Source: Mohammed VI University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Morocco	younes Oujidi	Berkane

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed VI University Hospital

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amelioration of PaO2/FiO2	the investigators recoordeed Blood gas analysis before and after Prone position	through study completion, an average of 1 yea