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

• Sponsor: Walid HABRE (Other)
• Overall Status: Completed
• CT.gov ID: NCT04359407
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome Coronavirus 2; Electric Impedance; Prone Positioning	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 Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome
• Actual Study Start Date: Apr 27, 2020
• Actual Primary Completion Date: May 10, 2021
• Actual Study Completion Date: May 10, 2021

Outcome Measures

Primary Outcome Measures

1. 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

1. Intrapulmonary shunt [One hour before turning to prone or supine positioning]

   Changes in intrapulmonary shunt fraction

2. Volumetric capnography [One hour before turning to prone or supine positioning]

   Changes in the phase three slope of the volumetric capnogram

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Geneva	Geneva		Switzerland	1206

Sponsors and Collaborators

• Walid HABRE

Investigators

• Principal Investigator: Walid Habre, MD, PhD, University of Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT04359407
• Other Study ID Numbers: 2020-00896
• First Posted: Apr 24, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

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

Study Results

No Results Posted as of Jul 21, 2021