Awake Pronation for Covid-19 Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid-19 Infection

Intervention / Treatment
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* Procedure: Prone Position (PP)


Participation Criteria
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Eligibility Criteria
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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 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 systolic blood pressure severe arrythmia of myocardial infarction need for sedation intolerance to PP pregnancy Body mass index (BMI) > 35 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen and Prone Position (PP)<br>Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day | Procedure: Prone Position (PP)<br>* Prone the patients on oxygen for at least 10 hrs a day<br>|
| Active Comparator: Oxygen<br>Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% | Procedure: Prone Position (PP)<br>* Prone the patients on oxygen for at least 10 hrs a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in respiratory pattern | recording of tidal volume (when possible) and respiratory frequency | 1 month | 
| daily changes in the ratio SaO2/FiO2 | Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2) | 1 month | 
| dyspnea | using a dedicated scale (i.e. Borg numbered from 0 to 10) | 1 month | 
| comfort during PP | using a dedicated visual analog scale (VAS with a lenght of 20 cm) | 1 month |