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

Completed

• Conditions: Prone Positioning; Severe Acute Respiratory Syndrome Coronavirus 2; Electric Impedance

• Registration Number: NCT04359407
• Lead Sponsor: Walid HABRE

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.

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 Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-04-27
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tidal electrical Impedance	One hour before turning to prone or supine positioning	Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland