Awake Pronation for Covid-19 Treatment

Last updated: April 15, 2021
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04667286
1117/2020/Sper/AOUBo
  • Ages 18-100
  • All Genders

Study Summary

Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.

None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • confirmed COVID-19 infection using PCR
  • Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min
  • O2 therapy initiated <72 hrs
  • informed consent

Exclusion

Exclusion Criteria:

  • Glasgow Coma Scale (GCS) < 13
  • pH< 7,45, PaCO2 >45 mmHg
  • need for HFNC, CPAP, NIV or intubation
  • hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolicblood pressure
  • severe arrythmia of myocardial infarction
  • need for sedation
  • intolerance to PP
  • pregnancy
  • Body mass index (BMI) > 35 kg/m2.

Study Design

Total Participants: 100
Study Start date:
January 16, 2021
Estimated Completion Date:
July 01, 2021

Study Description

Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.

These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position.

None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion.

This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.

Connect with a study center

  • Sant'Orsola Malpighi

    Bologna, 40185
    Italy

    Active - Recruiting

  • Bolzano Hospital

    Bolzano,
    Italy

    Active - Recruiting

  • University of Modena

    Modena,
    Italy

    Active - Recruiting

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