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Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS
Sponsor: Pontificia Universidad Catolica de Chile
Summary
Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are: * Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ? * How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ? Researchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS. Participants will: * Receive prone position either in prolonged (\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days * Be followed for up to 90 days to assess their clinical evolution
Official title: Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2025-04-07
Completion Date
2028-01
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Daily prone position sessions
Prone position sessions will be extended at least 16 hours, but no longer than 24 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.
Prolonged prone position sessions
Prone position sessions will be extended at least 48 hours AND until PaO2/FiO2 ratio is ≥ 200, but no longer than 120 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.
Locations (38)
Hospital Britanico
Buenos Aires, Argentina
Sanatorio Güemes
Buenos Aires, Argentina
Sanatorio Mitre
Buenos Aires, Argentina
Hospital San Martin de la Plata, Argentina
La Plata, Argentina
Hospital Vera Barros
La Rioja, Argentina
Hospital Privado de comunidad
Mar del Plata, Argentina
Hospital Leonardo Guzmán
Antofagasta, Chile
Hospital Clínico Herminda Martín
Chillan, Chile
Hospital Guillermo Grant Benavente
Concepción, Chile
Hospital San Juan de Dios de Curicó
Curicó, Chile
Hospital Regional Dr. Ernesto Torres Galdames
Iquique, Chile
Complejo Asistencial Dr. Victor Ríos Ruiz
Los Ángeles, Chile
Hospital Base San Jose de Osorno
Osorno, Chile
Hospital de Quilpué
Quilpué, Chile
Hospital Franco Ravera Zunino
Rancagua, Chile
Clínica Las Condes
Santiago, Chile
Clínica San Carlos de Apoquindo
Santiago, Chile
Clínica Santa Maria
Santiago, Chile
Clínica Universidad de los Andes
Santiago, Chile
Complejo Asistencial Dr. Sótero del Rio
Santiago, Chile
Hospital Barros Luco
Santiago, Chile
Hospital Clínico UC Christus
Santiago, Chile
Hospital Clínico Universidad de Chile
Santiago, Chile
Hospital Del Salvador Providencia
Santiago, Chile
Hospital Dra. Eloisa Diaz
Santiago, Chile
Hospital Padre Hurtado
Santiago, Chile
Hospital Santiago Oriente Dr. Luis Tizné Brousse
Santiago, Chile
Hospital Dr. Hernán Henríquez Aravena
Temuco, Chile
Hospital Carlos Van Buren
Valparaíso, Chile
Clínica Universidad de La Sabana y Unisabana Center for Translational Science (UCTS) de la Universidad de La Sabana
Cundinamarca, Colombia
Hospital Eugenio Espejo
Quito, Ecuador
Hospital Civil Fray Antonio Alcalde
Guadalajara, Mexico
Hospital Juárez de México
Mexico City, Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico
Hospital General San Juan del Río
Querétaro, Mexico
Hospital Español
Montevideo, Uruguay
Hospital Pasteur
Montevideo, Uruguay