Vaken buklägesbehandling för att reducera intubationsfrekvens, mortalitet och långtidseffekter vid Covid-19.

Bakgrund:

COVID-19 can lead to pneumonia with severe acute hypoxemic respiratory failure with the need for high FiO2 and invasive ventilation. The use of prone positioning (PP) increases the PaO2/FiO2-ratio and reduces mortality in moderate to severe ARDS. "Awake" PP in non-intubated spontaneously patients (APP), is feasible and transiently improves oxygenation in patients with hypoxemic acute respiratory failure.

Furthermore, APP may decrease intubation rates in patients with moderate ARDS. Hypoxemia is what usually necessitates intubation and ventilator therapy in Covid-19 patients. Therefore, we hypothesize that a protocol for awake PP in patients treated with high-flow nasal cannula oxygenation could reduce the rate of intubation and thereby reduce mortality and morbidity in severe Covid-19 disease.

Målsättning:

Determine if a protocol for APP with high flow nasal cannula reduces the rate of intubation and/or mortality in awake spontaneous breathing covid-19 patients with moderate to severe hypoxemic respiratory failure. In a follow-up study, we aim to quantify residual effects on the respiratory system 6 months after discharge.

Arbetsplan: To include 240 adults 18-years or older with confirmed or strongly suspected infection with SARS-CoV-2,

Patients will be block randomized 1:1 to a prone positioning protocol with a prone position target of 16 hours/day OR standard care.

Primary outcome is the rate of intubation. Secondary outcomes include PaO2/FiO2 ratio, admission to the ICU, time from inclusion to intubation, time on mechanical ventilation, 7- and 30-day mortality and complication rate. In a subset of patients, lung volumes and aereation will be determined with EIT, with follow-up at 6 months after discharge.

All included patients will be called for follow-up spirometry at 6 months.

The collected data will also be included in an international Meta-trial, based on 6 similar and simultaneously started studies with a goal of including 2010 patients with Covid-19. Betydelse:

The COVID-19 pandemic causes immense pressure on the health care system and the society as a whole. Ventilator shortage is an issue, and invasive mechanical ventilation is associated with a high mortality rate. APP is an inexpensive treatment that could reduce the need of intubation. The contribution of PROFLO to the Meta-trial PRONE maximizes the impact and the chance of providing high quality evidence for or against prone positioning in hypoxaemic Covid-19 patients.