Extended Prone Positioning for Intubated ARDS

NCT07126964 | Recruiting DMC

• 2 other identifiers: APHP2409342025-A00785-44
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) is an acutely induced respiratory failure characterised by the appearance of bilateral alveolar opacities on imaging and hypoxemia(1). Among strategies that have proved beneficial in terms of patient outcome, prone position (PP) is one associated with the greatest impact in terms of reduction in mortality, with PP sessions of 17h on average(2). The benefit of PP is to better homogenize the stress and strain applied to the lung by invasive ventilation. In a multicentric retrospective study involving COVID-19-related intubated ARDS patients, a strategy of extended PP, where PP was maintained for a median duration of 40 hours (h), was associated with increased survival compared to standard PP where each session lasted less than 24h(10). The main objective of this study is to investigate whether extended PP, defined as 40-hour PP sessions, can significantly reduce mortality of patients with invasively ventilated, severe ARDS, at day 28 after inclusion, compared to standard, 16-hour, PP sessions. The primary endpoint is all-cause mortality 28 days after inclusion. The study is a prospective, randomised, open-label, two-group parallel, multicenter trial comparing 40-hour extended PP to 16-hour standard PP in patients with moderate to severe ARDS. After inclusion, patients will be randomised either to standard PP, or extended PP. In the control arm, patients will be turned prone for 16-hour sessions. In the intervention arm, patients will be turned prone for 40h. In both groups, maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions to last 24 hours in the comparator group, and 48 hours in the intervention group. Inclusion criteria will be: severe ARDS, with ARDS defined according to the 2012 Berlin definition; and the severity defined as a PaO2/FiO2 ratio of \<150 mm Hg, with an FiO2 of ≥ 60% persisting for at least 4h after optimization of ventilatory setting. Exclusion criteria will be : PP during the same Intensive care unit ( ICU ) stay and before inclusion, ECMO before PP, arterio-venous ECMO, persistent PaO₂/FiO₂ ratios \<150 mm Hg, with FiO2 ≥ 60% on all arterial blood gases collected over a 24-hour period without prompting study inclusion, spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• All-cause mortality 28 days after inclusion

  28 days after inclusion

Secondary Outcomes (13)

• All-cause mortality 90 days after inclusion

  90 days after inclusion

• The biologically confirmed ventilator associated pneumonia incidence per-1000 days of invasive ventilation

  Up to day 28

• Use of inhaled NO during ICU stay

  Up to day 28

• Use of ECMO, during ICU stay

  Up to day 28

• Number of days alive free of invasive ventilation at days 28 and 90

  Up to 90 days after inclusion

Study Arms (2)

40-hour prone session (intervention)

EXPERIMENTAL

Patients will undergo PP sessions lasting for 16 hours. Maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions in the comparator group, to last a maximum of 24 hours.

Other: 40-hour prone session (intervention)

16-hour prone session (control)

ACTIVE COMPARATOR

Patients will undergo PP sessions lasting for 16 hours. Maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions in the comparator group, to last a maximum of 24 hours.

Other: 16-hour prone session (control)

Interventions

40-hour prone session (intervention) OTHER

Patients will undergo PP sessions lasting for 16 hours. Maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions in the comparator group, to last a maximum of 24 hours.

40-hour prone session (intervention)

16-hour prone session (control) OTHER

Patients will undergo PP sessions lasting for 16 hours. Maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions in the comparator group, to last a maximum of 24 hours.

16-hour prone session (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years
• Admitted to ICU.
• Under invasive ventilation for a maximum of 5 days.
• Meeting the 2012 Berlin criteria for ARDS
• Plateau pressure \< 35 cm of H2O at the time of screening
• PaO2/FiO2 ≤ 150 mmHg with FiO2 ≥ 60% and Spo2 between 92 and 96% after optimization by setting PEEP to 10 mmHg, sedation levels optimization and, if necessary, administration of neuromuscular blockers to ensure patient-ventilator synchrony, with VT ≤ 8 ml/kg PBW and Pplateau \< 30 cm H2O.

You may not qualify if:

• Spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge
• Home oxygen supplementation
• Care limited to comfort measures only
• Already included in PROSECO
• Pregnancy, subject deprived of freedom, Person under conservartorship, no insurance
• Refusal to participate expressed by the patient or his/her healthcare proxy or a close relative if present

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Thaïs Walter, Dr

  University Hospital Saint-Louis Lariboisière, APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaïs Walter, Dr

CONTACT

33. (0)6. 29. 81. 50. 92; thais.walter@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 17, 2025
• Study Start: October 18, 2025
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): October 18, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-10

Locations

FR (1)