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Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19 (DeCOPO)

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prone position
Supine position
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

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

Inclusion Criteria:

  • Aged ≥ 18 years,
  • Admitted to ICU within 72 hours,
  • Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
  • Having acute hypoxemic respiratory failure with a [PaO2/FiO2] ratio between 100 mmHg and 300 mmHg,
  • Having given free and informed written consent,
  • Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

  • Unable to achieve a prone position for mobility reasons,
  • Unable to achieve a prone position due to agitation whatever the cause,
  • With clinical occlusive syndrome in order to limit the risk of inhalation,
  • Having a contraindication to the use of the esophageal catheter,
  • Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
  • Having hypercapnia indicating the use of non-invasive ventilation (PaO2> 50 mmHg),
  • Having severe hypoxemia defined by PaO2 / FiO2 <100mmHg,
  • Ongoing pregnancy or breastfeeding,
  • Subject to a measure for the protection of justice.

Sites / Locations

  • Hopital Européen
  • Hopital La Timone
  • Hopital Saint Joseph
  • Hopital Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

[PP sequence 1] - Wash-out - [SP sequence 2]

[SP sequence 1] - Wash-out - [PP sequence 2]

Arm Description

Outcomes

Primary Outcome Measures

[PaO2 / FiO2] ratio
Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.

Secondary Outcome Measures

ΔPeso measured using an esophageal balloon catheter
ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.
Concentration of CO2 at the end of expiration (EtCO2, mmHg)
Capnometry measurements by breathing on a mouthpiece connected to an online analyzer. The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.
Intensity of dyspnea
assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible
Tolerance of the technique
measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possible
Tolerance of the technique
measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible
The occurrence of side effects due to PP
Oxygen desaturation (SaO2 <90%), occurrence of hemodynamic instability (Systolic blood pressure <80 mmHg or heart rate >120 mmHg for >1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.

Full Information

First Posted
September 8, 2020
Last Updated
March 7, 2022
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT04543760
Brief Title
Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19
Acronym
DeCOPO
Official Title
Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
March 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

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

5. Study Description

Brief Summary
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[PP sequence 1] - Wash-out - [SP sequence 2]
Arm Type
Other
Arm Title
[SP sequence 1] - Wash-out - [PP sequence 2]
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Prone position
Intervention Description
prone positioning in spontaneous ventilation
Intervention Type
Other
Intervention Name(s)
Supine position
Intervention Description
supine positiong in spontaneous ventilation
Primary Outcome Measure Information:
Title
[PaO2 / FiO2] ratio
Description
Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
ΔPeso measured using an esophageal balloon catheter
Description
ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.
Time Frame
6 hours
Title
Concentration of CO2 at the end of expiration (EtCO2, mmHg)
Description
Capnometry measurements by breathing on a mouthpiece connected to an online analyzer. The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.
Time Frame
6 hours
Title
Intensity of dyspnea
Description
assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible
Time Frame
6 hours
Title
Tolerance of the technique
Description
measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possible
Time Frame
6 hours
Title
Tolerance of the technique
Description
measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible
Time Frame
6 hours
Title
The occurrence of side effects due to PP
Description
Oxygen desaturation (SaO2 <90%), occurrence of hemodynamic instability (Systolic blood pressure <80 mmHg or heart rate >120 mmHg for >1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18 years, Admitted to ICU within 72 hours, Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography), Having acute hypoxemic respiratory failure with a [PaO2/FiO2] ratio between 100 mmHg and 300 mmHg, Having given free and informed written consent, Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: Unable to achieve a prone position for mobility reasons, Unable to achieve a prone position due to agitation whatever the cause, With clinical occlusive syndrome in order to limit the risk of inhalation, Having a contraindication to the use of the esophageal catheter, Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours, Having hypercapnia indicating the use of non-invasive ventilation (PaO2> 50 mmHg), Having severe hypoxemia defined by PaO2 / FiO2 <100mmHg, Ongoing pregnancy or breastfeeding, Subject to a measure for the protection of justice.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel LEHINGUE, M.D
Organizational Affiliation
Hopital Saint Joseph Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Hopital La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
beginning 3 months and ending 2 years following article publication
IPD Sharing Access Criteria
The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. The proposal should be directed to the PI, Dr Lehingue.

Learn more about this trial

Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19

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