Clinical trial NCT06966310: Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy
Official title: Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Community-acquired Pneumonia
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 1078
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Intubation within 28 days of randomization
timeFrame: From randomization to day 28
Secondary outcomes:
measure: Patient comfort before the first prone session, using a visual analogue scale.
timeFrame: From randomization to 6 hours
measure: Patient comfort during the first prone session, using a visual analogue scale.
timeFrame: From randomization to day 1
measure: Patient comfort after the first prone session, using a visual analogue scale.
timeFrame: From randomization to day 1
measure: 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.
timeFrame: From randomization to 6 hours
measure: Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group.
timeFrame: From randomization to day 1
measure: Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group.
timeFrame: From randomization to day 1
measure: Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale.
timeFrame: From day 1 to day 3
measure: Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3.
timeFrame: From day 1 to day 3
measure: Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
timeFrame: From randomization to day 28 or intensive care unit discharge whichever occurs first
measure: Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
timeFrame: From randomization to day 28 or intensive care unit discharge whichever occurs first
measure: Time to intensive care unit discharge and time to hospital discharge (up to day 28).
timeFrame: From randomization to day 28
measure: Mortality
timeFrame: From randomization to day 90
measure: Mortality
timeFrame: From randomization to day 28 or intensive care unit and hospital discharge
measure: Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups
timeFrame: From randomization to 24 hours post randomization
measure: Evolution of patient's quality of life
timeFrame: At 90 days
measure: Evolution of patient's quality of life
timeFrame: At 5 years
measure: Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first).
timeFrame: From randomization to day 28 or intensive care unit discharge whichever occurs first).
Other outcomes:
Locations:
city: Amiens
country: France
facility: Intensive care, University Hospital, Amiens
city: Angers
country: France
facility: Intensive care, University Hospital, Angers
city: Argenteuil
country: France
facility: Intensive care, University Hospital, Argenteuil
city: Belfort
country: France
facility: Intensive care, University Hospital, Belfort
city: Besançon
country: France
facility: Intensive care, University Hospital, Besancon
city: Blois
country: France
facility: Intensive care, University Hospital, Blois
city: Bordeaux
country: France
facility: Intensive care, University Hospital, Bordeaux
city: Bourg-en-Bresse
country: France
facility: Intensive care, University Hospital, Bourg en Bresse
city: Bourges
country: France
facility: Intensive care, University Hospital, Bourges
city: Brest
country: France
facility: Intensive care, University Hospital, Brest
city: Béthune
country: France
facility: Intensive care, University Hospital, Bethune
city: Colombes
country: France
facility: Intensive care, University Hospital, Colombes
city: Dieppe
country: France
facility: Intensive care, University Hospital, Dieppe
city: Dijon
country: France
facility: Intensive care, University Hospital, Dijon
city: Dreux
country: France
facility: Intensive care, University Hospital, Dreux
city: Garche
country: France
facility: Intensive care, University Hospital, Garches
city: Grenoble
country: France
facility: Intensive care, University Hospital, Grenoble
city: La Roche-sur-Yon
country: France
facility: Intensive care, University Hospital, La Roche sur Yon
city: Le Mans
country: France
facility: Intensive care, University Hospital, Le Mans
city: Lens
country: France
facility: Intensive care, University Hospital, Lens
city: Lille
country: France
facility: Intensive care, University Hospital, Lille
city: Lorient
country: France
facility: Intensive care, University Hospital, Lorient
city: Lyon
country: France
facility: Intensive care, University Hospital, Lyon
city: Lyon
country: France
facility: Intensive care, University Hospital, Lyon
city: Morlaix
country: France
facility: Intensive care, University Hospital, Morlaix
city: Nantes
country: France
facility: Intensive care, University Hospital, Nantes
city: Nice
country: France
facility: Intensive care, University Hospital, Nice
city: Nice
country: France
facility: Intensive care, University Hospital, Nice
city: Orléans
country: France
facility: Intensive care, University Hospital, Orléans
city: Paris
country: France
facility: Intensive care, University Hospital, Cochin
city: Paris
country: France
facility: Intensive care, University Hospital, Tenon
city: Poitiers
country: France
facility: Intensive care, University Hospital, Poitiers
city: Rouen
country: France
facility: Intensive care, University Hospital, Rouen
city: Saint-Brieuc
country: France
facility: Intensive care, University Hospital, Saint Brieuc
city: Saint-Nazaire
country: France
facility: Intensive care, University Hospital, Saint Nazaire
city: Strasbourg
country: France
facility: Intensive care, University Hospital, Strasbourg
city: Strasbourg
country: France
facility: Intensive care, University Hospital, Strasbourg
city: Tours
country: France
facility: Intensive care, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Stephan EHRMANN
role: STUDY_DIRECTOR
References: