NCT04667286

Awake Pronation for Covid-19 Treatment

Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Covid-19 Infection

Interventions

Type	Name	Description
PROCEDURE	Prone Position (PP)	Prone the patients on oxygen for at least 10 hrs a day

Timeline

• Start date: 2021-01-16
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2020-12-14
• Last updated: 2021-04-19

Locations

3 sites across 1 country: Italy