Prone Positioning and Regional Ventilation in Mechanically Ventilated COVID-19 Patients

NCT04359407 | Completed

• 1 other identifier: 2020-00896
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; Electric Impedance; Prone Positioning

Outcome Measures

Primary Outcomes (1)

• Tidal electrical Impedance

  Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas

  One hour before turning to prone or supine positioning

Secondary Outcomes (2)

• Intrapulmonary shunt

  One hour before turning to prone or supine positioning

• Volumetric capnography

  One hour before turning to prone or supine positioning

Interventions

Prone positioning OTHER

Change the positioning of the COVID patients who are intubated and mechanically ventilated from supine to prone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe acute lung injury induced by the coronavirus necessitating intubation and ventilation with positioning on the ventral side.

You may qualify if:

• Patients fulfilling all the following criteria are eligible for the study:
• Mechanically ventilated
• Fit the Berlin Definition for moderate or severe acute respiratory distress syndrome (arterial oxygen partial pressure over inspiratory fraction of oxygen less than 200 mmHg)
• Infection with coronavirus confirmed
• Scheduled to undergo prone positioning

You may not qualify if:

• Patients with pacemakers, defibrillators or other electrically active implants
• Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
• Patients with chest tubes
• History of thoracic surgery or lung resection

Sponsors & Collaborators

• Walid HABRE: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

Location

Related Publications (1)

• Dos Santos Rocha A, Diaper J, Balogh AL, Marti C, Grosgurin O, Habre W, Petak F, Sudy R. Effect of body position on the redistribution of regional lung aeration during invasive and non-invasive ventilation of COVID-19 patients. Sci Rep. 2022 Jun 30;12(1):11085. doi: 10.1038/s41598-022-15122-9.

  PMID: 35773299 DERIVED

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Walid Habre, MD, PhD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: April 27, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)