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OpenTrials
Completed

NCT Number: NCT04359407

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, 1206, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone Positioning

Other

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

Primary outcomes

  1. Tidal electrical Impedance

    Time frame: 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 outcomes

  1. Intrapulmonary shunt

    Time frame: One hour before turning to prone or supine positioning

    Changes in intrapulmonary shunt fraction

  2. Volumetric capnography

    Time frame: One hour before turning to prone or supine positioning

    Changes in the phase three slope of the volumetric capnogram

Sponsors and collaborators

Lead sponsor

Walid HABRE

Other

Registry information

Official study 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

Acronym: COVID-19_EIT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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