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

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.

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Prone position; Other: Supine position

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Hôpital La Timone
  • Marseille, France, 13003
    • Hôpital Européen
  • Marseille, France, 13008
    • Hopital Saint Joseph
  • Marseille, France, 13915
    • Hopital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: [PP sequence 1] - Wash-out - [SP sequence 2]	Other: Prone position; prone positioning in spontaneous ventilation; Other: Supine position; supine positiong in spontaneous ventilation
Other: [SP sequence 1] - Wash-out - [PP sequence 2]	Other: Prone position; prone positioning in spontaneous ventilation; Other: Supine position; supine positiong in spontaneous ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 hours
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.	6 hours
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	6 hours
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	6 hours
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	6 hours
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.	6 hours

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Samuel LEHINGUE, M.D, Hôpital Saint Joseph Marseille

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): March 14, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: 2020-04-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No