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

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ClinicalTrials.gov Identifier: NCT04359407
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Walid HABRE, University Hospital, Geneva

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
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.

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Study Type : Observational
Estimated Enrollment : 16 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 : April 27, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359407


Contacts
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Contact: Walid Habre, Md, PhD +41223468677 walid.habre@hcuge.ch
Contact: Adam L Balogh, MD, PhD +41766335163 adam.balogh@unige.ch

Locations
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Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1206
Contact: Walid Habre, MD, PhD    +41 22 37 27 504    walid.habre@hcuge.ch   
Sponsors and Collaborators
Walid HABRE
Investigators
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Principal Investigator: Walid Habre, MD, PhD University of Geneva
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Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04359407    
Other Study ID Numbers: 2020-00896
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases