Status:
UNKNOWN
Awake Pronation for Covid-19 Treatment
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Azienda USL Reggio Emilia - IRCCS
Azienda Ospedaliera di Bolzano
Conditions:
Covid-19 Infection
Eligibility:
All Genders
18-100 years
Phase:
NA
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. ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04667286
Start Date
January 16 2021
End Date
July 1 2021
Last Update
April 19 2021
Active Locations (3)
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1
Sant'Orsola Malpighi
Bologna, Italy, 40185
2
Bolzano Hospital
Bolzano, Italy
3
University of Modena
Modena, Italy