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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Prone the patients on oxygen for at least 10 hrs a day
Sant'Orsola Malpighi
Bologna, Italy
RECRUITINGBolzano Hospital
Bolzano, Italy
RECRUITINGUniversity of Modena
Modena, Italy
RECRUITINGnumber of day free of ventilatory support
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation
Time frame: 1 month
changes in respiratory pattern
recording of tidal volume (when possible) and respiratory frequency
Time frame: 1 month
daily changes in the ratio SaO2/FiO2
Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)
Time frame: 1 month
dyspnea
using a dedicated scale (i.e. Borg numbered from 0 to 10)
Time frame: 1 month
comfort during PP
using a dedicated visual analog scale (VAS with a lenght of 20 cm)
Time frame: 1 month
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