Awake Pronation for Covid-19 Treatment

NCT04667286 | Unknown DMC

• 1 other identifier: 1117/2020/Sper/AOUBo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Covid-19 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• changes in respiratory pattern

  1 month

• daily changes in the ratio SaO2/FiO2

  1 month

• dyspnea

  1 month

• comfort during PP

  1 month

Other Outcomes (1)

• number of hours on PP

  1 month

Study Arms (2)

Oxygen and Prone Position (PP)

EXPERIMENTAL

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)

Oxygen

ACTIVE COMPARATOR

Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%

Procedure: Prone Position (PP)

Interventions

Prone Position (PP) PROCEDURE

Prone the patients on oxygen for at least 10 hrs a day

Oxygen; Oxygen and Prone Position (PP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Azienda Ospedaliera di Bolzano: collaborator
• Azienda Ospedaliero-Universitaria di Modena: collaborator

Study Sites (3)

Sant'Orsola Malpighi

Bologna, 40185, Italy

RECRUITING

Bolzano Hospital

Bolzano, Italy

RECRUITING

University of Modena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• stefano nava, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

stefano nava

CONTACT

+393333751828; stefanava@gmail.com

stefano nava

CONTACT

+3930512144454; stefanava@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and chief of respiratory and critical care unit

Model Details: randomised trial

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: January 16, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)