Could prone positioning increase lung function for patients with severe COVID-19 infection?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Patients with a defined respiratory failure due to COVID‐19 infection are randomly included in a standard care arm and a prone positioning arm in 1:1 blocks of four. Randomization will be provided using app.studyrandomizer.com. Patients in the prone positioning arm should lay in a prone position or semi‐recumbent position with the head of the bed elevated to 30 degrees with the target of 16 hours per day and night. For patients in the standard arm prone or semi‐recumbent position is neither prohibited nor encouraged and may be prescribed by the treating physician at their discretion. All other treatment or interventions for all included patients will follow ordinary local guidelines at the present hospital and are not affected by the study protocol. For a small subgroup of 30 patients, 15 from each group, electrical impedance tomography will be measured during one occasion. Measurements will be performed before placed in a prone position, intermittent during 2 hours in a prone position and during 1 hour in a semi‐recumbent position. During this part samples of arterial blood gases are collected and respiratory rate, as well as hemodynamic parameters, are registered. Dyspnea is assessed with the modified Borg scale and discomfort with a visual analogue scale. Follow‐up is at 2 months after the end of inclusion. CONDITION: Respiratory function in patients with respiratory failure due to COVID‐19 infection ; Infections and Infestations PRIMARY OUTCOME: Rate of intubation for mechanical ventilation support, recorded in EHR at inclusion and once if applied. Timeframe 30 days after inclusion. SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 34beb6dcf8ddd16a4a06550b7299c50f68d21185
First added on: Jun 16, 2020