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Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure (ProneSpontCov)

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physiological effects of awake prone position in COVID 19 patients
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 18 Years (Adult, Older Adult)
  • Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
  • Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg
  • Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
  • Written informed consent of the patient

Exclusion Criteria:

  • Contra-indication to prone position including pregnancy
  • Presence of pacemaker
  • Severe hypoxemia with PaO2/FiO2 < 100 mmHg
  • Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

Sites / Locations

  • Assistance Publique Höpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patients in prone position followed by dorsal decubitus

dorsal decubitus followed by prone decubitus

Arm Description

patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.

patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.

Outcomes

Primary Outcome Measures

Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.
Electrical Impedance Tomography (EIT)

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
August 12, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04632602
Brief Title
Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure
Acronym
ProneSpontCov
Official Title
Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
November 29, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.
Detailed Description
Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each patient will be his own control. The order of the experimental periods will be: arm A: prone position followed by dorsal decubitus arm B: dorsal decubitus followed by ventral decubitus A 30-minute wash-out period is set between the end of sequence 1 and the start of sequence 2.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients in prone position followed by dorsal decubitus
Arm Type
Other
Arm Description
patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.
Arm Title
dorsal decubitus followed by prone decubitus
Arm Type
Other
Arm Description
patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.
Intervention Type
Other
Intervention Name(s)
physiological effects of awake prone position in COVID 19 patients
Intervention Description
Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale). Measurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period.
Primary Outcome Measure Information:
Title
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.
Description
Electrical Impedance Tomography (EIT)
Time Frame
2hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than 18 Years (Adult, Older Adult) Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab) Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen Written informed consent of the patient Exclusion Criteria: Contra-indication to prone position including pregnancy Presence of pacemaker Severe hypoxemia with PaO2/FiO2 < 100 mmHg Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Höpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure

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