System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT06966310 on ClinicalTrials.gov

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

  • Sponsor: Centre Hospitalier Universitaire de Tours
  • Enrollment: 1078 (Estimated)
  • Study start: 2025-11-30 (Actual)
  • Primary completion: 2029-11-01 (Estimated)
  • Study completion: 2034-10-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: 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.

Coordinating investigator 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.

Conditions

  • Community-acquired Pneumonia

Intervention / Treatment

  • Other: Prone position

Primary Outcome Measures

  • Intubation within 28 days of randomization (From randomization to day 28)
    Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.

Countries

France

Locations and Investigators

  • Intensive care, University Hospital, Amiens, Amiens, France (Not yet recruiting)
    • Clément BRAULT
    • Clément BRAULT (Principal Investigator)
  • Intensive care, University Hospital, Angers, Angers, France (Not yet recruiting)
  • Intensive care, University Hospital, Argenteuil, Argenteuil, France (Not yet recruiting)
    • Gaëtan PLANTEFEVE
    • Gaëtan PLANTEFEVE (Principal Investigator)
  • Intensive care, University Hospital, Belfort, Belfort, France (Not yet recruiting)
    • Julio BADIE
    • Julio BADIE (Principal Investigator)
  • Intensive care, University Hospital, Besancon, Besançon, France (Not yet recruiting)
    • Thibault VIEILLE
    • Thibault VIEILLE (Principal Investigator)
  • Intensive care, University Hospital, Bethune, Béthune, France (Not yet recruiting)
    • Ghada SBOUI
    • Ghada SBOUI (Principal Investigator)
  • Intensive care, University Hospital, Blois, Blois, France (Not yet recruiting)
    • Julien GROUILLE
    • Julien GROUILLE (Principal Investigator)
  • Intensive care, University Hospital, Bordeaux, Bordeaux, France (Not yet recruiting)
    • Alexandre BOYER
    • Alexandre BOYER (Principal Investigator)
  • Intensive care, University Hospital, Bourg en Bresse, Bourg-en-Bresse, France (Not yet recruiting)
    • Nicholas SEDILLOT
    • Nicholas SEDILLOT (Principal Investigator)
  • Intensive care, University Hospital, Bourges, Bourges, France (Recruiting)
    • Anna BOURREAU
    • Anna BOURREAU (Principal Investigator)
  • Intensive care, University Hospital, Brest, Brest, France (Not yet recruiting)
    • Gwénaël PRAT
    • Gwénaël PRAT (Principal Investigator)
  • Intensive care, University Hospital, Colombes, Colombes, France (Not yet recruiting)
    • Damien ROUX
    • Damien ROUX Damien (Principal Investigator)
  • Intensive care, University Hospital, Dieppe, Dieppe, France (Not yet recruiting)
    • Pierre-Louis DECLERCQ
    • Pierre-Louis DECLERCQ (Principal Investigator)
  • Intensive care, University Hospital, Dijon, Dijon, France (Recruiting)
    • Jean-Pierre QUENOT
    • Jean-Pierre QUENOT (Principal Investigator)
  • Intensive care, University Hospital, Dreux, Dreux, France (Not yet recruiting)
    • Florent BAVOZET
    • Florent BAVOZET (Principal Investigator)
  • Intensive care, University Hospital, Garches, Garche, France (Not yet recruiting)
    • Djillali ANNANE
    • Djillali ANNANE (Principal Investigator)
  • Intensive care, University Hospital, Grenoble, Grenoble, France (Not yet recruiting)
    • Guilhem WATTECAMPS
    • Guilhem WATTECAMPS (Principal Investigator)
  • Intensive care, University Hospital, La Roche sur Yon, La Roche-sur-Yon, France (Recruiting)
    • Jean-Claude LACHERADE
    • Jean-Claude LACHERADE (Principal Investigator)
  • Intensive care, University Hospital, Le Mans, Le Mans, France (Recruiting)
    • Mickael LANDAIS
    • Mickael LANDAIS (Principal Investigator)
  • Intensive care, University Hospital, Lens, Lens, France (Recruiting)
    • Camille PROUTEAU
    • Camille PROUTEAU (Principal Investigator)
  • Intensive care, University Hospital, Lille, Lille, France (Not yet recruiting)
    • Saadalla NSEIR
    • Saadalla NSEIR (Principal Investigator)
  • Intensive care, University Hospital, Lorient, Lorient, France (Not yet recruiting)
    • Guillaume GRILLET
    • Guillaume GRILLET (Principal Investigator)
  • Intensive care, University Hospital, Lyon, Lyon, France (Not yet recruiting)
    • Hodane YONIS
    • Hodane YONIS (Principal Investigator)
  • Intensive care, University Hospital, Lyon, Lyon, France (Not yet recruiting)
    • Laurent ARGAUD
    • Laurent ARGAUD (Principal Investigator)
  • Intensive care, University Hospital, Morlaix, Morlaix, France (Recruiting)
    • Pierre-Yves EGRETEAU
    • Pierre-Yves EGRETEAU (Principal Investigator)
  • Intensive care, University Hospital, Nantes, Nantes, France (Recruiting)
    • Jean REIGNIER
    • Jean REIGNIER (Principal Investigator)
  • Intensive care, University Hospital, Nice, Nice, France (Not yet recruiting)
    • Clément SACCHERI
    • Clément SACCHERI (Principal Investigator)
  • Intensive care, University Hospital, Nice, Nice, France (Not yet recruiting)
    • Robert ALEXANDRE
    • Robert ALEXANDRE (Principal Investigator)
  • Intensive care, University Hospital, Orléans, Orléans, France (Not yet recruiting)
    • François BARBIER
    • François BARBIER (Principal Investigator)
  • Intensive care, University Hospital, Cochin, Paris, France (Not yet recruiting)
    • Jean-Paul MIRA
    • Jean-Paul MIRA (Principal Investigator)
  • Intensive care, University Hospital, Tenon, Paris, France (Not yet recruiting)
    • Muriel FARTOUKH
    • Muriel FARTOUKH (Principal Investigator)
  • Intensive care, University Hospital, Poitiers, Poitiers, France (Recruiting)
    • Arnaud THILLE
    • Arnaud THILLE (Principal Investigator)
  • Intensive care, University Hospital, Rouen, Rouen, France (Not yet recruiting)
    • Grégoire JOLLY
    • Grégoire JOLLY (Principal Investigator)
  • Intensive care, University Hospital, Saint Brieuc, Saint-Brieuc, France (Recruiting)
    • François LEGAY
    • François LEGAY (Principal Investigator)
  • Intensive care, University Hospital, Saint Nazaire, Saint-Nazaire, France (Recruiting)
    • Patricia COUROUBLE
    • Patricia COUROUBLE (Principal Investigator)
  • Intensive care, University Hospital, Strasbourg, Strasbourg, France (Not yet recruiting)
    • Julien DEMISELLE
    • Julien DEMISELLE (Principal Investigator)
  • Intensive care, University Hospital, Strasbourg, Strasbourg, France (Not yet recruiting)
    • Jean-Etienne HERBRECHT
    • Jean-Etienne HERBRECHT (Principal Investigator)
  • Intensive care, University Hospital, Tours, Tours, France (Recruiting)

Study Officials