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AzTrials

Acute Respiratory Distress SyndromeePRONENCT06854627

Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS

A study testing Daily prone position sessions and Prolonged prone position sessions in people with Acute Respiratory Distress Syndrome, run by Pontificia Universidad Catolica de Chile at 38 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
Daily prone position sessions and Prolonged prone position sessions
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
38 sitesin 6 countries
Study dates
7 Apr 2025to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

38 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Alejandro Bruhn, MD, PhD contact

+56223543292

abruhn@uc.cl

Eduardo Kattan, MD, PhD contact

994793024

e.kattan@gmail.com

38 sites in 6 countries

Chile23 sites, 23 recruiting

  • Hospital Leonardo Guzmán

    Antofagasta

    Vinko Tomicic, MD, vtomicic@gmail.com

    Vinko Tomicic, MD

    Recruiting

  • Hospital Clínico Herminda Martín

    Chillan

    Pablo Nvarrete, MD, pdnavarr@gmail.com

    Pablo Navarrete, MD

    Recruiting

  • Hospital Guillermo Grant Benavente

    Concepción

    Paula Fernández, MD, fernandezandrade@gmail.com

    Paula Fernández, MD

    Recruiting

  • Hospital San Juan de Dios de Curicó

    Curicó

    Nelson Perez, MD, nperez21@gmail.com

    Nelson Perez, MD

    Recruiting

  • Hospital Regional Dr. Ernesto Torres Galdames

    Iquique

    Roberto Galvez, MD, Dr.robertogalvez@yahoo.com

    Roberto Galvez, MD

    Recruiting

  • Complejo Asistencial Dr. Victor Ríos Ruiz

    Los Ángeles

    Fernando Tirapegui, MD, ftirapegui@uc.cl

    Fernando Tirapegui, MD

    Recruiting

  • Hospital Base San Jose de Osorno

    Osorno

    Mario Grade, MD, mario.grage@redsalud.gob.cl

    Mario Grage, MD

    Recruiting

  • Hospital de Quilpué

    Quilpué

    Mario Bruna, MD, mbrunap74@gmail.com

    Mario Bruna, MD

    Recruiting

  • Hospital Franco Ravera Zunino

    Rancagua

    Victor Vásquez, MD, victor.vasquezg@redsalud.gob.cl

    Victor Vásquez, MD

    Recruiting

  • Clínica Las Condes

    Santiago

    Martín Benites, MD, PhD(c), benitesmartinh@gmail.com

    Martin Benites, MD, PhD(c)

    Recruiting

  • Clínica San Carlos de Apoquindo

    Santiago

    Rene Medina, PT, rmedina@ucchristus.cl

    Rene Medina, PT

    Recruiting

  • Clínica Santa Maria

    Santiago

    Tomas Regueria, MD, tregueira@gmail.com

    Tomas Regueira, MD

    Recruiting

  • Clínica Universidad de los Andes

    Santiago

    Juan Castillo, MD, jucastillo@clinicauandes.cl

    Juan Castillo, MD

    Recruiting

  • Complejo Asistencial Dr. Sótero del Rio

    Santiago

    Carolina Ruiz, MD, ccruiz@uc.cl

    Carolina Ruiz, MD

    Recruiting

  • Hospital Barros Luco

    Santiago

    Juan Pablo Valdivia, MD, jp.valdivia@hotmail.com

    Juan Pablo Valdivia, MD

    Recruiting

  • Hospital Clínico UC Christus

    Santiago

    Roque Basoalto, PT, PhD, roque.basoalto@gmail.com

    Roque Basoalto, PT, PhD

    Recruiting

  • Hospital Clínico Universidad de Chile

    Santiago

    Rodrigo Cornejo, MD, rcornejor@hcuch.cl

    Rodrigo Cornejo, MD

    Recruiting

  • Hospital Del Salvador Providencia

    Santiago

    José Antonio Escalona, MD, josan553@gmail.com

    José Antonio Escalona, MD

    Recruiting

  • Hospital Dra. Eloisa Diaz

    Santiago

    Eduardo Chinchón, MD, doctorchinchon@gmail.com

    Eduardo Chinchón, MD

    Recruiting

  • Hospital Padre Hurtado

    Santiago

    Sofia Leighton, MD, sofia.leighton@gmail.com

    Sofia Leighton, MD

    Recruiting

  • Hospital Santiago Oriente Dr. Luis Tizné Brousse

    Santiago

    Marco Antonio Merino, MD, marco.merino.uribe@gmail.com

    Marco Antonio Merino, MD

    Recruiting

  • Hospital Dr. Hernán Henríquez Aravena

    Temuco

    Jaime Contreras, MD, jaime.contreras.bizama@gmail.com

    Jaime Contreras, MD

    Recruiting

  • Hospital Carlos Van Buren

    Valparaíso

    Romyna Baghetti, MD, Romyna.baghetti@gmail.com

    Romyna Baghetti@gmail.com, MD

    Recruiting

Other trials in Chile

Argentina6 sites, 6 recruiting

  • Hospital Britanico

    Buenos Aires

    Facundo Bianchini, MD, facu.bianchini@hotmail.com

    Facundo Bianchini, MD

    Recruiting

  • Sanatorio Güemes

    Buenos Aires

    Ignacio Romero, MD, dr.ignacio.romero@gmail.com

    Ignacio Romero, MD

    Recruiting

  • Sanatorio Mitre

    Buenos Aires

    Maria Lucia Gimenez, MD, gimenezmarialucia@hotmail.com

    Maria Lucia Gimenez, MD

    Recruiting

  • Hospital San Martin de la Plata, Argentina

    La Plata

    Mauricio Gastón Nucciarone, MD, mauricionucciarone@gmail.com

    Mauricio Gastón Nucciarone, MD

    Recruiting

  • Hospital Vera Barros

    La Rioja

    Evangelina Zamora, MD, evangepz@hotmail.com

    Evangelina Zamora, MD

    Recruiting

  • Hospital Privado de comunidad

    Mar del Plata

    Mariano Esperatti, MD, marianoesperatti@gmail.com

    Mariano Esperatti, MD

    Recruiting

Other trials in Argentina

Mexico5 sites, 5 recruiting

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara

    Miguel Ibarra, MD, drmiguelibarra@hotmail.com

    Miguel Ibarra, MD

    Recruiting

  • Hospital Juárez de México

    Mexico City

    José Carlos Gasca, MD, pepeska01@hotmail.com

    Jose Carlos Gasca, MD

    Recruiting

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City

    Silvio Antonio Ñamendys-Silva, MD, snamendys@gmail.com

    Silvio Antonio Ñamendys-Silva, MD

    Recruiting

  • Instituto Nacional de Enfermedades Respiratorias

    Mexico City

    Irene Balam, MD, irenebalara@gmail.com

    Irene Balam, MD

    Recruiting

  • Hospital General San Juan del Río

    Querétaro

    Orlando Orlando, MD, orlando_rpn@hotmail.com

    Orlando Orlando, MD

    Recruiting

Other trials in Mexico

Uruguay2 sites, 2 recruiting

  • Hospital Español

    Montevideo

    Nicolas Nin, MD, niconin@hotmail.com

    Nicolas Nin, MD

    Recruiting

  • Hospital Pasteur

    Montevideo

    Julio Pontet, MD, jpontet2003@gmail.com

    Julio Pontet, MD

    Recruiting

Other trials in Uruguay

Colombia1 site, 1 recruiting

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

    Cundinamarca

    Luis Felipe Reyes, MD, luis.reyes5@unisabana.edu.co

    Luis Felipe Reyes, MD

    Recruiting

Other trials in Colombia

Ecuador1 site, 1 recruiting

  • Hospital Eugenio Espejo

    Quito

    Manuel Jibaja, MD, mjibaja79@gmail.com

    Manuel Jibaja, MD

    Recruiting

Other trials in Ecuador

About this study

Official title: Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial

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 ?
Read more

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
Read the detailed description

Acute Respiratory Distress Syndrome (ARDS) is a severe condition with a 40% mortality rate. The management of ARDS still relies largely on supportive therapy. The cornerstone of this support is protective mechanical ventilation to prevent ventilator-induced lung injury (VILI). For patients with moderate-to- severe forms of ARDS, specifically mechanically ventilated patients with PaO2/FiO2 ratios below 150, the use of prone position has shown to be a fundamental intervention which became one of the most relevant pillars of the ICU management during the Covid-19 pandemics. Several studies have shown that prone position not only improves oxygenation, but can attenuate the mechanisms of VILI, which would explain its benefit in terms of mortality. The physiologic benefits of prone position are progressive along time, but they can be lost rapidly after returning to supìne position.

Since the publication of the landmark PROSEVA study (Guerin 2013), which showed that ventilating patients in prone position decreased mortality, the standard approach to prone position has been the use of daily sessions of 16 to 20 hours. With this approach most patients usually require 3 to 4 prone sessions (intermittent daily prone position). However, due to the excessive workload of ICU staff during the Covid-19 pandemics, several centers decided to extend the sessions beyond 24 hours to decrease the frequency of position changes in patients with Covid-19 associated ARDS. Several centers reported their experience with prolonged sessions showing that it was feasible and that the rate of adverse events appeared to be similar to those previously reported with the standard daily sessions. The largest experience reported up to now was a retrospective study which included 417 patients from 15 centers in Chile, where a continuous prolonged prone position was applied as a nationwide strategy (Cornejo 2022). Most patients required a single prone session of 4 (3-5) days. Although the study lacked a control group, the mortality and rate of adverse events was rather low compared to other series of patients with similar characteristics. A non-randomized controlled study from 3 hospital in US even showed that compared to patients treated with standard prone sessions (< 24 hours), patients treated with prolonged sessions had a lower risk of mortality (Okin 2023). However, other reports have shown conflicting results regarding the potential benefit associated to prolonging prone position sessions beyond 24 hours. Recent guidelines have acknowledged that the optimal duration of prone position sessions is unknown and must be further investigated (Grasselli 2023). Prolonging prone position sessions may ensure that this lung protective intervention is maintained throughout the acute phase of ARDS.

The goal of the present study is to compare the effects of a continuous prolonged prone position versus an intermittent daily prone position on mortality and other relevant outcomes, as well as on the incidence of adverse events potentially related to prone position, in mechanically ventilated patients with moderate-to-severe ARDS.

The study will be a randomized, multicenter, two-arm parallel-group, investigator-led clinical trial with allocation concealment and intention-to-treat analysis. Patients allocated to the experimental arm (prolonged prone position) will receive prone position sessions for a minimum of 48 hours, which will be further extended until PaO2/FiO2 is ≥ 200, or until reaching the maximum of 120 hours. Patients allocated to the control arm (intermittent prone position) will receive prone position sessions for a minimum of 16 hours and a maximum of 24 hours. In both groups prone sessions may be repeated if PaO2/FiO2 ratio falls below 150 after being returned to supine position during the first 7 days (intervention period).

Being tested
Daily prone position sessions, Prolonged prone position sessions
Keywords
ACUTE RESPIRATORY DISTRESS SYNDROME, RESPIRATORY FAILURE, PRONE POSITION, MECHANICAL VENTILATION
Medical subject headings
Respiratory Distress Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily prone position sessionsProcedure or surgery

    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 sessionsProcedure or surgery

    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.

Study groups in NCT06854627
Study groupRoleWhat they receive
Intermittent Prone PositionActive comparatorThis arm will receive prone position sessions as applied in the PROSEVA trial (Guerin 2013)
Receives: Procedure: Daily prone position sessions
Prolonged Prone PositionExperimentalThis arm will receive prone position sessions as applied in a previous multicenter study during the COVID-19 pandemics (Cornejo 2022)
Receives: Procedure: Prolonged prone position sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day mortality

    All-cause mortality

    Measured: 28 days

Secondary outcomes (3)

  1. 90-day mortality

    All-cause mortality

    Measured: 90 days

  2. Ventilator-free days

    Days-free from mechanical ventilation and alive up to day 28

    Measured: 28 days

  3. Hospital-free days at day 28

    Days-free from Hospital and alive up to day 28

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start7 Apr 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study do not use Drug, Biological/Vaccine, or Combination Product.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06854627
Sponsor's protocol ID
230606007
Acronym
ePRONE
Status last verified
Apr 2026
First submitted
21 Jan 2025
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: anonymized data will be shared among reasonable request to the corresponding author.

Publications

  • 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.

    PubMed 36441352

  • 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.

    PubMed 23688302

  • 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.

    PubMed 37326646

  • 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.

    PubMed 36343687

Questions about this trial

What is this clinical trial studying?

A study testing Daily prone position sessions and Prolonged prone position sessions in people with Acute Respiratory Distress Syndrome, run by Pontificia Universidad Catolica de Chile at 38 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Chile, Argentina, Mexico, Uruguay, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alejandro Bruhn, MD, PhD (+56223543292, abruhn@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854627, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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