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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 28, 2021
First Posted Date August 6, 2021
Last Update Posted Date August 13, 2021
Actual Study Start Date January 1, 2020
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2021)
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
Original Primary Outcome Measures
 (submitted: July 31, 2021)
amelioration of PaO2/FiO2 [ Time Frame: through study completion, an average of 1 yea ]
we recoordeed Blood gas analysis before and after Prone position
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prone Position During ECMO in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Hypoxaemic Patient
Official Title Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco
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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 23 patients admitted to the intensive care unit of different genders and ethnicities were included.
Condition
  • SARS CoV 2 Infection
  • Hypoxemic Respiratory Failure
Intervention Other: Prone position on ECMO patient
blood gas analysis before and after PP
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 31, 2021)
23
Original Actual Enrollment Same as current
Actual Study Completion Date January 30, 2021
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Morocco
Removed Location Countries  
 
Administrative Information
NCT Number NCT04995289
Other Study ID Numbers MohammedVIUH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Younes Oujidi, Mohammed VI University Hospital
Study Sponsor Mohammed VI University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Mohammed VI University Hospital
Verification Date August 2021