Clinical trial NCT04359407: Prone Positioning and Regional Ventilation in Mechanically Ventilated COVID-19 Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Electric Impedance
Prone Positioning
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tidal electrical Impedance
timeFrame: One hour before turning to prone or supine positioning
Secondary outcomes:
measure: Intrapulmonary shunt
timeFrame: One hour before turning to prone or supine positioning
measure: Volumetric capnography
timeFrame: One hour before turning to prone or supine positioning
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University of Geneva
name: Walid Habre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.