About this trial
Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome.
Among invasively mechanically ventilated patients with ARDS and presenting a PaO2/FiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.
Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.
Coordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients admitted to an intensive care unit or intermediate care unit
Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
Disqualifiers
Positive SARS-COV2 test within the last 30 days
Indication for immediate intubation
Patients for whom a "do not intubate" decision has been made
Chest trauma or other contraindication to prone position
Trial design
Parallel
Treatments tested in this trial
Prone position
Other interventiondepending on tolerance, the objective is to spend as much time as possible, up to 16h and beyond, in prone position per period of 24 hours. For each session the patients will be encouraged to stay as long as possible in the prone position (i.e. ideally 4-8 hours each session).
Treatment groups
Trial outcomes
Primary outcomes
Intubation within 28 days of randomization
Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.
Secondary outcomes
Patient comfort before the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Patient comfort during the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Patient comfort after the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group.
Sponsors and contacts
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