Covid-19 Infection
Conditions
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.
Interventions
PROCEDUREProne Position (PP)
Prone the patients on oxygen for at least 10 hrs a day
Sponsors
Azienda USL Reggio Emilia - IRCCS
Azienda Ospedaliera di Bolzano
Azienda Ospedaliero-Universitaria di Modena
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomised trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of hours on PP | 1 month | recording of the actual time spent in PP |
Countries
Italy
Contacts
Primary Contactstefano nava
Backup Contactstefano nava
Outcome results
None listed