Awake prone positioning for adults with community-acquired pneumonia on high-flow nasal oxygen.
Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19
NA · University Hospital, Tours · NCT06966310
This trial will test whether asking adults with community-acquired pneumonia who are on high-flow nasal oxygen to lie on their stomach while awake can reduce the need for a breathing tube.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1078 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours (other) |
| Locations | 38 sites (Amiens and 37 other locations) |
| Trial ID | NCT06966310 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults in ICU or intermediate care with suspected community-acquired pneumonia on high-flow nasal oxygen (≥30 L/min) and PaO2/FiO2 <300 who can consent and are affiliated with French social security or equivalent.
Not a fit: Patients who need immediate intubation, have do-not-intubate orders, clear contraindications to prone positioning, are pregnant or breastfeeding, or require non-invasive ventilation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower the rate of mechanical ventilation and help patients come off high-flow oxygen sooner.
How similar studies have performed: Prone positioning is proven to reduce mortality in invasively ventilated ARDS patients and recent non-intubated COVID-19 studies and small case series have suggested awake prone positioning can reduce intubation or speed weaning, but evidence in non-COVID community-acquired pneumonia remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 37 other locations
- Intensive care, University Hospital, Amiens — Amiens, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Angers — Angers, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Argenteuil — Argenteuil, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Belfort — Belfort, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Besancon — Besançon, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Bethune — Béthune, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Blois — Blois, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Bordeaux — Bordeaux, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Bourg en Bresse — Bourg-en-Bresse, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Bourges — Bourges, France (RECRUITING)
- Intensive care, University Hospital, Brest — Brest, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Colombes — Colombes, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Dieppe — Dieppe, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Dijon — Dijon, France (RECRUITING)
- Intensive care, University Hospital, Dreux — Dreux, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Garches — Garche, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Grenoble — Grenoble, France (NOT_YET_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, Lille — Lille, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Lorient — Lorient, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Lyon — Lyon, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Lyon — Lyon, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Morlaix — Morlaix, France (RECRUITING)
- Intensive care, University Hospital, Nantes — Nantes, France (RECRUITING)
- Intensive care, University Hospital, Nice — Nice, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Nice — Nice, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Orléans — Orléans, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Cochin — Paris, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Tenon — Paris, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Poitiers — Poitiers, France (RECRUITING)
- Intensive care, University Hospital, Rouen — Rouen, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Saint Brieuc — Saint-Brieuc, France (RECRUITING)
- Intensive care, University Hospital, Saint Nazaire — Saint-Nazaire, France (RECRUITING)
- Intensive care, University Hospital, Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
- Intensive care, University Hospital, Tours — Tours, France (RECRUITING)
Study contacts
- Study coordinator: Stephan EHRMANN
- Email: stephanehrmann@gmail.com
- Phone: 2.47.47.38.55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Community-acquired Pneumonia