Awake Pronation for Covid-19 Treatment

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

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

Study Overview

• Status: Recruiting
• Conditions: Covid-19 Infection
• Intervention / Treatment: Procedure: Prone Position (PP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: stefano nava; Phone Number: +393333751828; Email: stefanava@gmail.com
• Study Contact Backup: Name: stefano nava; Phone Number: +3930512144454; Email: stefanava@gmail.com

Study Locations

• Italy
  • Bologna, Italy, 40185
    • Recruiting
    • Sant'Orsola Malpighi
  • Bolzano, Italy
    • Recruiting
    • Bolzano Hospital
    • Contact: roberto dongilli
  • Modena, Italy
    • Recruiting
    • University of Modena
    • Contact: enrico clini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of hours on PP	recording of the actual time spent in PP	1 month

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Azienda Ospedaliero-Universitaria di Modena; Azienda Unita Sanitaria Locale Reggio Emilia; Azienda Ospedaliera di Bolzano
• Investigators: Principal Investigator: Stefano Nava, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1117/2020/Sper/AOUBo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No