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

• Sponsor: Direction Centrale du Service de Santé des Armées (Other)
• Overall Status: Completed
• CT.gov ID: NCT04603755
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Actual Duration (Months): 4.7
• Patients Per Site: 25
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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	Phase
SARS-CoV Infection; Acute Respiratory Distress Syndrome	Device: Electrical Impedance tomography

Study Design

• Study Type: Observational
• Actual Enrollment: 50 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: Oct 26, 2020
• Actual Primary Completion Date: Mar 18, 2021
• Actual Study Completion Date: Mar 18, 2021

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de la Timone	Marseille		France	13005
2	Hôpital d'Instruction des Armées Sainte-Anne	Toulon		France	83800

Sponsors and Collaborators

• Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Direction Centrale du Service de Santé des Armées
• ClinicalTrials.gov Identifier: NCT04603755
• Other Study ID Numbers: 2020-COVID19-16; 2020-A02823-36
• First Posted: Oct 27, 2020
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome

Study Results

No Results Posted as of Sep 16, 2021