Awake Pronation for Covid-19 Treatment
- Conditions
- Covid-19 Infection
- Interventions
- Procedure: Prone Position (PP)
- Registration Number
- NCT04667286
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxygen and Prone Position (PP) Prone Position (PP) 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 Oxygen Prone Position (PP) Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%
- Primary Outcome Measures
Name Time Method number of day free of ventilatory support 1 month 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
- Secondary Outcome Measures
Name Time Method changes in respiratory pattern 1 month recording of tidal volume (when possible) and respiratory frequency
daily changes in the ratio SaO2/FiO2 1 month Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)
dyspnea 1 month using a dedicated scale (i.e. Borg numbered from 0 to 10)
comfort during PP 1 month using a dedicated visual analog scale (VAS with a lenght of 20 cm)
Trial Locations
- Locations (3)
Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Bolzano Hospital
🇮🇹Bolzano, Italy
University of Modena
🇮🇹Modena, Italy