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Completed

NCT Number: NCT04543760

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Européen, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Prone position

Other

prone positioning in spontaneous ventilation

supine position

Other

supine positiong in spontaneous ventilation

Primary outcomes

  1. [PaO2 / FiO2] ratio

    Time frame: 6 hours

    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 outcomes

  1. ΔPeso measured using an esophageal balloon catheter

    Time frame: 6 hours

    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.

  2. Concentration of CO2 at the end of expiration (EtCO2, mmHg)

    Time frame: 6 hours

    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.

  3. Intensity of dyspnea

    Time frame: 6 hours

    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

  4. Tolerance of the technique

    Time frame: 6 hours

    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

  5. Tolerance of the technique

    Time frame: 6 hours

    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. The occurrence of side effects due to PP

    Time frame: 6 hours

    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.

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study 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.

Acronym: DeCOPO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Mar 22, 2022

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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