Respiratory function in patients with respiratory failure due to COVID-19 infection Infections and Infestations
Conditions
Interventions
Current interventions as of 24/11/2022:
Patients with a defined respiratory failure due to COVID-19 infection are randomly included in a standard care arm and a prone positioning arm i
Sponsors
Uppsala County Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 year or older 2. Admission to a hospital with confirmed or strongly suspected COVID-19 infection 3. Hypoxic respiratory failure defined as a PaO2/FiO2 ratio = 20 kPa (150 mmHg) and/or a FiO2 of = 0.5 to reach a SpO2 of 94% for more than 1 hour 4. Oxygen supplementation (ongoing or planned) with high flow nasal cannuale or noninvasive ventilating support
Exclusion criteria
Exclusion criteria: 1. Severe nasal obstruction or other contraindication to high flow nasal cannulae 2. Patient unable to lay prone or in the face forward position 3. Immediate need for intubation 4. Severe and/or uncontrolled hemodynamic instability 5. Previous intubation for COVID-19 pneumonia (i.e. step down patients) 6. Pregnancy 7. Known terminal illness with life expectancy less than 1 year 8. Decision not to intubate 9. Inability to understand oral or written study information and/or to cooperate with instructions necessary to complete the allocated intervention 10. Inability to understand oral or written study information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of intubation for mechanical ventilation support, recorded in EHR at inclusion and once if applied. Timeframe 30 days after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| All measures are included in the ordinary treatment and according to local regulations registered or automatically collected in the EHR or PDMS from where data is exported to a database protocol: 1. Time in prone position (pp); every time the patient changes position the timepoint will be recorded in a preprinted protocol (CRF) or the PDMS if available, total time measured once per day and night in hospital 2. Need for vasoactive drugs, day and time for start, change of infusion rate or stop of vasopressor infusion, recorded in PDMS or EHR, evaluated once per day and night in hospital 3. Days on ventilator support, day and time of intubation and start of ventilator support, day and time of extubation and end of ventilator support, recorded in PDMS or EHR, checked once a day in hospital 4. In-hospital and ICU length of stay: timepoint recorded in the EHR when enrolled and discharge at hospital/ICU 5. Rate of complications reported in a preprinted protocol (CRF) every 24th hour after inclusion 6. 7- and 30-day mortality: day and time of death recorded in the EHR, checked once within a month after discharge from the hospital 7. Clinical improvement measured using WHO ordinal scale at baseline, day 7 and day 30 | — |
Countries
Sweden
Outcome results
None listed