Awake Pronation for Covid-19 Treatment

Covid-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667286
• Other study ID #: 1117/2020/Sper/AOUBo
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: stefano nava
• Phone: +393333751828
• Email: stefanava[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19 Infection

Intervention

Procedure:
• Prone Position (PP)
Prone the patients on oxygen for at least 10 hrs a day

Locations

Country	Name	City	State
Italy	Sant'Orsola Malpighi	Bologna
Italy	Bolzano Hospital	Bolzano
Italy	University of Modena	Modena

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Azienda Ospedaliera di Bolzano, Azienda Ospedaliero-Universitaria di Modena, Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of hours on PP	recording of the actual time spent in PP	1 month
Primary	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	changes in respiratory pattern	recording of tidal volume (when possible) and respiratory frequency	1 month
Secondary	daily changes in the ratio SaO2/FiO2	Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)	1 month
Secondary	dyspnea	using a dedicated scale (i.e. Borg numbered from 0 to 10)	1 month
Secondary	comfort during PP	using a dedicated visual analog scale (VAS with a lenght of 20 cm)	1 month