Awake Pronation for Covid-19 Treatment

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Covid-19 Infection

Treatments: Procedure: Prone Position (PP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04667286

1117/2020/Sper/AOUBo

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Oxygen and Prone Position (PP)

Experimental group

Description:

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

Treatment:

Procedure: Prone Position (PP)

Oxygen

Active Comparator group

Description:

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

Treatment:

Procedure: Prone Position (PP)