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

The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Electric Impedance; Severe Acute Respiratory Syndrome Coronavirus 2; Prone Positioning
• Intervention / Treatment: Other: Prone positioning

Detailed Description

Patients with acute respiratory distress syndrome (ARDS) frequently develop atelectasis in dorsal lung regions because of gravity and the compression by the heart and the diaphragm. Since lung perfusion is predominantly distributed in lower lung regions, a reduction of ventilation in these areas results in further ventilation-perfusion mismatch, called shunt. The development of atelectatic lung regions necessitate the use of higher ventilation pressures, which in turn results in excessive transpulmonary pressures and ventilation-induced lung injury in the ventral regions. Therefore it is common to promote the prone position in patients with ARDS in order to improve ventilation-perfusion matching and thus, protect the ventral regions from hyperinflation. In patients with COVID-19-related ARDS, the value of such therapeutic strategy based on placing in prone position has not been completely elucidated. The aims of the study are to determine whether prone positioning improves dorsal regional ventilation when compared to supine position. Moreover, another aim is to assess the changes in intrapulmonary shunt following patient position changes.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrapulmonary shunt	Changes in intrapulmonary shunt fraction	One hour before turning to prone or supine positioning
Volumetric capnography	Changes in the phase three slope of the volumetric capnogram	One hour before turning to prone or supine positioning

Collaborators and Investigators

• Sponsor: Walid HABRE

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2020
• Primary Completion (ACTUAL): May 10, 2021
• Study Completion (ACTUAL): May 10, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease; Severe Acute Respiratory Syndrome; Coronavirus Infections; Syndrome
• Other Study ID Numbers: 2020-00896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No