Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome (COVIDEIT)

September 14, 2021 updated by: Direction Centrale du Service de Santé des Armées

There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved.

If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19.

However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Hopital de la Timone
      • Toulon, France, 83800
        • Hôpital d'Instruction des Armées Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of patients who have been admitted to the intensive care unit for SARS-CoV-2 ARDS.

Description

Inclusion Criteria:

  • Patients admitted to the intensive care unit for SARS-CoV-2 ARDS
  • Under controlled invasive ventilation for less than 7 days

Exclusion Criteria:

  • Pneumothorax
  • Deformation of the rib cage
  • Contraindication to Electrical Impedance Tomography
  • Pregnant or breastfeeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position
Time Frame: Up to 7 days

The percentage of derecruitment of dependent areas will be measured every day with Electrical Impedance Tomography.

The response to prone position will be assessed every day.
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2020

Primary Completion (ACTUAL)

March 18, 2021

Study Completion (ACTUAL)

March 18, 2021

Study Registration Dates

First Submitted

October 24, 2020

First Submitted That Met QC Criteria

October 24, 2020

First Posted (ACTUAL)

October 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-COVID19-16
  • 2020-A02823-36 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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