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

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ClinicalTrials.gov Identifier: NCT04603755
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Brief Summary:

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.


Condition or disease Intervention/treatment
SARS-CoV Infection Acute Respiratory Distress Syndrome Device: Electrical Impedance tomography

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022



Intervention Details:
  • Device: Electrical Impedance tomography
    Electrical Impedance tomography recording during 5 minutes every day during 7 days


Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603755


Contacts
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Contact: Michael CARDINALE, MD 483162204 ext +33 michael.cardinale@intradef.gouv.fr

Locations
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France
Hôpital d'Instruction des Armées Sainte-Anne Recruiting
Toulon, France, 83800
Contact: Michael CARDINALE, MD    483162204 ext +33    michael.cardinale@intradef.gouv.fr   
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04603755    
Other Study ID Numbers: 2020-COVID19-16
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections