Awake prone positioning for adults with community-acquired pneumonia on high-flow nasal oxygen.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial enrolls adults admitted to ICU or intermediate care with suspected community-acquired pneumonia who require high-flow nasal oxygen (≥30 L/min) and have impaired oxygenation (PaO2/FiO2 <300 or SpO2/FiO2 <315). Eligible patients who are not recently SARS-CoV-2 positive and who have no contraindications to prone positioning will undergo periods of awake prone positioning while receiving nasal high flow. Outcomes include progression to intubation, death, and duration of high-flow support, with comparisons to usual positioning practices. The protocol excludes patients with immediate need for intubation, do-not-intubate orders, indications for non-invasive ventilation, chest trauma, pregnancy, or legal protection status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Intensive care, University Hospital, Bourges
  Bourges, France Recruiting
• Intensive care, University Hospital, Dijon
  Dijon, France Recruiting
• Intensive care, University Hospital, La Roche sur Yon
  La Roche-sur-Yon, France Recruiting
• Intensive care, University Hospital, Le Mans
  Le Mans, France Recruiting
• Intensive care, University Hospital, Lens
  Lens, France Recruiting
• Intensive care, University Hospital, Morlaix
  Morlaix, France Recruiting

Study contacts

• Study coordinator: Stephan EHRMANN
• Email: stephanehrmann@gmail.com
• Phone: 2.47.47.38.55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.