NCT04995289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

July 28, 2021

Last Update Submit

August 6, 2021

Conditions

Keywords

ECMOARDSProne positionCOVIDcompliance

Outcome Measures

Primary Outcomes (1)

  • amelioration of PaO2/FiO2

    the investigators recoordeed Blood gas analysis before and after Prone position

    through study completion, an average of 1 yea

Interventions

blood gas analysis before and after PP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

23 patients admitted to the intensive care unit of different genders and ethnicities were included.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

younes Oujidi

Berkane, 9999, Morocco

Location

MeSH Terms

Conditions

COVID-19Respiratory InsufficiencyPatient Compliance

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 6, 2021

Study Start

January 1, 2020

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations