NCT06854627

Brief 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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
780

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
6 countries

38 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2025Jan 2028

First Submitted

Initial submission to the registry

January 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 18, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

January 21, 2025

Last Update Submit

May 14, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

ACUTE RESPIRATORY DISTRESS SYNDROMERESPIRATORY FAILUREPRONE POSITIONMECHANICAL VENTILATION

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    All-cause mortality

    28 days

Secondary Outcomes (3)

  • 90-day mortality

    90 days

  • Ventilator-free days

    28 days

  • Hospital-free days at day 28

    28 days

Study Arms (2)

Intermittent Prone Position

ACTIVE COMPARATOR

This arm will receive prone position sessions as applied in the PROSEVA trial (Guerin 2013)

Procedure: Daily prone position sessions

Prolonged Prone Position

EXPERIMENTAL

This arm will receive prone position sessions as applied in a previous multicenter study during the COVID-19 pandemics (Cornejo 2022)

Procedure: Prolonged prone position sessions

Interventions

Daily prone position sessionsPROCEDURE

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.

Intermittent Prone Position
Prolonged prone position sessionsPROCEDURE

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.

Prolonged Prone Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Endotracheal intubation and mechanical ventilation for less than 72 hours
  • Moderate-severe ARDS defined as:
  • Within 1 week of a known clinical insult or new or worsening respiratory symptoms
  • Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules
  • Respiratory failure not fully explained by cardiac failure or fluid overload
  • PaO2/FiO2 \< 150 mmHg in supine position
  • Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours

You may not qualify if:

  • Contraindications for prone positioning such as intracranial pressure \> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks
  • Patient on extracorporeal membrane oxygenation (ECMO) before randomization
  • Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)
  • Known pregnancy
  • Anticipating withdrawal of life support or shift to palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Hospital Britanico

Buenos Aires, Argentina

RECRUITING

Sanatorio Güemes

Buenos Aires, Argentina

RECRUITING

Sanatorio Mitre

Buenos Aires, Argentina

RECRUITING

Hospital San Martin de la Plata, Argentina

La Plata, Argentina

RECRUITING

Hospital Vera Barros

La Rioja, Argentina

RECRUITING

Hospital Privado de comunidad

Mar del Plata, Argentina

RECRUITING

Hospital Leonardo Guzmán

Antofagasta, Chile

RECRUITING

Hospital Clínico Herminda Martín

Chillan, Chile

RECRUITING

Hospital Guillermo Grant Benavente

Concepción, Chile

RECRUITING

Hospital San Juan de Dios de Curicó

Curicó, Chile

RECRUITING

Hospital Regional Dr. Ernesto Torres Galdames

Iquique, Chile

RECRUITING

Complejo Asistencial Dr. Victor Ríos Ruiz

Los Ángeles, Chile

RECRUITING

Hospital Base San Jose de Osorno

Osorno, Chile

RECRUITING

Hospital de Quilpué

Quilpué, Chile

RECRUITING

Hospital Franco Ravera Zunino

Rancagua, Chile

RECRUITING

Clínica Las Condes

Santiago, Chile

RECRUITING

Clínica San Carlos de Apoquindo

Santiago, Chile

RECRUITING

Clínica Santa Maria

Santiago, Chile

RECRUITING

Clínica Universidad de los Andes

Santiago, Chile

RECRUITING

Complejo Asistencial Dr. Sótero del Rio

Santiago, Chile

RECRUITING

Hospital Barros Luco

Santiago, Chile

RECRUITING

Hospital Clínico UC Christus

Santiago, Chile

RECRUITING

Hospital Clínico Universidad de Chile

Santiago, Chile

RECRUITING

Hospital Del Salvador Providencia

Santiago, Chile

RECRUITING

Hospital Dra. Eloisa Diaz

Santiago, Chile

RECRUITING

Hospital Padre Hurtado

Santiago, Chile

RECRUITING

Hospital Santiago Oriente Dr. Luis Tizné Brousse

Santiago, Chile

RECRUITING

Hospital Dr. Hernán Henríquez Aravena

Temuco, Chile

RECRUITING

Hospital Carlos Van Buren

Valparaíso, Chile

RECRUITING

Clínica Universidad de La Sabana y Unisabana Center for Translational Science (UCTS) de la Universidad de La Sabana

Cundinamarca, Colombia

RECRUITING

Hospital Eugenio Espejo

Quito, Ecuador

RECRUITING

Hospital Civil Fray Antonio Alcalde

Guadalajara, Mexico

RECRUITING

Hospital Juárez de México

Mexico City, Mexico

RECRUITING

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

RECRUITING

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico

RECRUITING

Hospital General San Juan del Río

Querétaro, Mexico

RECRUITING

Hospital Español

Montevideo, Uruguay

RECRUITING

Hospital Pasteur

Montevideo, Uruguay

RECRUITING

Related Publications (4)

  • Cornejo RA, Montoya J, Gajardo AIJ, Graf J, Alegria L, Baghetti R, Irarrazaval A, Santis C, Pavez N, Leighton S, Tomicic V, Morales D, Ruiz C, Navarrete P, Vargas P, Galvez R, Espinosa V, Lazo M, Perez-Araos RA, Garay O, Sepulveda P, Martinez E, Bruhn A; SOCHIMI Prone-COVID-19 Group. Continuous prolonged prone positioning in COVID-19-related ARDS: a multicenter cohort study from Chile. Ann Intensive Care. 2022 Nov 28;12(1):109. doi: 10.1186/s13613-022-01082-w.

    PMID: 36441352BACKGROUND

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PMID: 23688302BACKGROUND

  • Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.

    PMID: 37326646BACKGROUND

  • Okin D, Huang CY, Alba GA, Jesudasen SJ, Dandawate NA, Gavralidis A, Chang LL, Moin EE, Ahmad I, Witkin AS, Hardin CC, Hibbert KA, Kadar A, Gordan PL, Lee H, Thompson BT, Bebell LM, Lai PS. Prolonged Prone Position Ventilation Is Associated With Reduced Mortality in Intubated COVID-19 Patients. Chest. 2023 Mar;163(3):533-542. doi: 10.1016/j.chest.2022.10.034. Epub 2022 Nov 4.

    PMID: 36343687BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Alejandro Bruhn, MD, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • Rodrigo Cornejo, MD, MBA

    University of Chile

    STUDY DIRECTOR

Central Study Contacts

Alejandro Bruhn, MD, PhD

CONTACT

+56223543292abruhn@uc.cl

Eduardo Kattan, MD, PhD

CONTACT

994793024e.kattan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
groups will be coded for the assessment of the outcomes
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Study do not use Drug, Biological/Vaccine, or Combination Product.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

March 3, 2025

Study Start

April 7, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

anonymized data will be shared among reasonable request to the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
will become available after the main paper is published, for 10 years.
Access Criteria
among reasonable request to the principal investigator

Locations

CL(23)AR(6)ME(5)CO(1)UR(2)EC(1)