Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy
NCT ID: NCT06966310
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1078 participants
INTERVENTIONAL
2025-05-19
2034-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prone position group
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.
Prone position
depending 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).
Control group
Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.
No interventions assigned to this group
Interventions
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Prone position
depending 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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Stephan EHRMANN
Role: STUDY_DIRECTOR
University Hospital, Tours
Locations
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Intensive care, University Hospital, Amiens
Amiens, , France
Intensive care, University Hospital, Angers
Angers, , France
Intensive care, University Hospital, Argenteuil
Argenteuil, , France
Intensive care, University Hospital, Belfort
Belfort, , France
Intensive care, University Hospital, Besancon
Besançon, , France
Intensive care, University Hospital, Bethune
Béthune, , France
Intensive care, University Hospital, Blois
Blois, , France
Intensive care, University Hospital, Bordeaux
Bordeaux, , France
Intensive care, University Hospital, Bourg en Bresse
Bourg-en-Bresse, , France
Intensive care, University Hospital, Bourges
Bourges, , France
Intensive care, University Hospital, Brest
Brest, , France
Intensive care, University Hospital, Colombes
Colombes, , France
Intensive care, University Hospital, Dieppe
Dieppe, , France
Intensive care, University Hospital, Dijon
Dijon, , France
Intensive care, University Hospital, Dreux
Dreux, , France
Intensive care, University Hospital, Garches
Garche, , France
Intensive care, University Hospital, Grenoble
Grenoble, , France
Intensive care, University Hospital, La Roche sur Yon
La Roche-sur-Yon, , France
Intensive care, University Hospital, Le Mans
Le Mans, , France
Intensive care, University Hospital, Lens
Lens, , France
Intensive care, University Hospital, Lille
Lille, , France
Intensive care, University Hospital, Lorient
Lorient, , France
Intensive care, University Hospital, Lyon
Lyon, , France
Intensive care, University Hospital, Lyon
Lyon, , France
Intensive care, University Hospital, Morlaix
Morlaix, , France
Intensive care, University Hospital, Nantes
Nantes, , France
Intensive care, University Hospital, Nice
Nice, , France
Intensive care, University Hospital, Nice
Nice, , France
Intensive care, University Hospital, Orléans
Orléans, , France
Intensive care, University Hospital, Cochin
Paris, , France
Intensive care, University Hospital, Tenon
Paris, , France
Intensive care, University Hospital, Poitiers
Poitiers, , France
Intensive care, University Hospital, Rouen
Rouen, , France
Intensive care, University Hospital, Saint Brieuc
Saint-Brieuc, , France
Intensive care, University Hospital, Saint Nazaire
Saint-Nazaire, , France
Intensive care, University Hospital, Strasbourg
Strasbourg, , France
Intensive care, University Hospital, Strasbourg
Strasbourg, , France
Intensive care, University Hospital, Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Clément BRAULT
Role: primary
Pierre ASFAR
Role: primary
Gaëtan PLANTEFEVE
Role: primary
Julio BADIE
Role: primary
Thibault VIEILLE
Role: primary
Ghada SBOUI
Role: primary
Julien GROUILLE
Role: primary
Alexandre BOYER
Role: primary
Nicholas SEDILLOT
Role: primary
Anna BOURREAU
Role: primary
Gwénaël PRAT
Role: primary
Damien ROUX
Role: primary
Pierre-Louis DECLERCQ
Role: primary
Jean-Pierre QUENOT
Role: primary
Florent BAVOZET
Role: primary
Djillali ANNANE
Role: primary
Guilhem WATTECAMPS
Role: primary
Jean-Claude LACHERADE
Role: primary
Mickael LANDAIS
Role: primary
Camille PROUTEAU
Role: primary
Saadalla NSEIR
Role: primary
Guillaume GRILLET
Role: primary
Hodane YONIS
Role: primary
Laurent ARGAUD
Role: primary
Pierre-Yves EGRETEAU
Role: primary
Jean REIGNIER
Role: primary
Clément SACCHERI
Role: primary
Robert ALEXANDRE
Role: primary
François BARBIER
Role: primary
Jean-Paul MIRA
Role: primary
Muriel FARTOUKH
Role: primary
Arnaud THILLE
Role: primary
Grégoire JOLLY
Role: primary
François LEGAY
Role: primary
Patricia COUROUBLE
Role: primary
Julien DEMISELLE
Role: primary
Jean-Etienne HERBRECHT
Role: primary
Stephan EHRMANN
Role: primary
Other Identifiers
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DR230003
Identifier Type: -
Identifier Source: org_study_id
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