Clinical trial NCT04667286: Awake Pronation for Covid-19 Treatment
Official title: Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid-19 Infection
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
name: Azienda Ospedaliera di Bolzano
name: Azienda Ospedaliero-Universitaria di Modena
First posted: 2020-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised trial
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of day free of ventilatory support
timeFrame: 1 month
Secondary outcomes:
measure: changes in respiratory pattern
timeFrame: 1 month
measure: daily changes in the ratio SaO2/FiO2
timeFrame: 1 month
measure: dyspnea
timeFrame: 1 month
measure: comfort during PP
timeFrame: 1 month
Other outcomes:
measure: number of hours on PP
timeFrame: 1 month
Locations:
city: Bologna
country: Italy
facility: Sant'Orsola Malpighi
city: Bolzano
country: Italy
facility: Bolzano Hospital
city: Modena
country: Italy
facility: University of Modena
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: stefano nava, MD
role: PRINCIPAL_INVESTIGATOR
References: