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

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

— COVID-19_EIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359407
• Other study ID #: 2020-00896
• Status: Completed
• Start date: April 27, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Electric Impedance
• Prone Positioning
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Walid HABRE

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intrapulmonary shunt	Changes in intrapulmonary shunt fraction	One hour before turning to prone or supine positioning
Secondary	Volumetric capnography	Changes in the phase three slope of the volumetric capnogram	One hour before turning to prone or supine positioning