NCT04603755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

October 24, 2020

Last Update Submit

September 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Electrical Impedance tomography recording during 5 minutes every day during 7 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital de la Timone

Marseille, 13005, France

Location

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83800, France

Location

Related Publications (1)

  • Cardinale M, Boussen S, Cungi PJ, Esnault P, Mathais Q, Bordes J, Meaudre E, Goutorbe P. Lung-Dependent Areas Collapse, Monitored by Electrical Impedance Tomography, May Predict the Oxygenation Response to Prone Ventilation in COVID-19 Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Jul 1;50(7):1093-1102. doi: 10.1097/CCM.0000000000005487. Epub 2022 Feb 11.

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesLung DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 27, 2020

Study Start

October 26, 2020

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations