Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy (PRONECAP)

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Community-acquired Pneumonia

Treatments: Other: Prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT06966310

DR230003

Details and patient eligibility

About

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.

We 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.

Enrollment: 1,078 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Person affiliated to a French social security system or equivalent
• Informed consent.

Exclusion criteria

• 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
• Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.
• Pregnant or breastfeeding woman
• Subjects who are under legal protection measure
• More than 8h awake prone positioning prior to inclusion
• More than 48h since intensive care unit or intermediate care unit admission.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,078 participants in 2 patient groups

Prone position group

Experimental group

Description:

patients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions.

Treatment:

Other: Prone position

Control group

No Intervention group

Description:

Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.