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NCT04603755 Clinical Trial

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

Acute Respiratory Distress Syndrome Clinical Trial

— COVIDEIT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04603755
Other study ID # 2020-COVID19-16
Secondary ID 2020-A02823-36
Status Completed
Phase
First received
Last updated
Start date October 26, 2020
Est. completion date March 18, 2021

Study information
Verified date September 2021
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 18, 2021
Est. primary completion date March 18, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hôpital de la Timone Marseille
France Hôpital d'Instruction des Armées Sainte-Anne Toulon

Sponsors (1)
Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position 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
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