Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome

NCT00527813 | Completed DMC

• 1 other identifier: 2007.474
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome; prone position; Acute respiratory distress syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• 28-day mortality from all causes

  28 days

Secondary Outcomes (1)

• 90-day mortality from all causes and incidence of ventilator-acquired pneumonia (VAP).

  90 days

Study Arms (2)

A

EXPERIMENTAL

prone position for at least 16 hours per day

Procedure: prone position

B

NO INTERVENTION

semi-recumbent position

Interventions

prone position PROCEDURE

prone position for at least 16 hours per day

A

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18 years or more, both gender
• Receiving endotracheal intubation and mechanical ventilation for less than 36 hours
• Presenting with a Severe ARDS :
• Acute onset
• PaO2/FiO2 ≤ 200 (≤ 26.7 kPa)
• Bilateral pulmonary infiltrates on frontal chest radiography
• Capillary wedge pressure \< 18 mm Hg if measured or no evidence for left atrial hypertension
• During since 12-24 hours
• AND with severity criteria : PaO2/FiO2 \< 150 mm Hg (\< 20 kPa) under FiO2 ≥ 0.6, PEEP ≥ 5 cm H2O and a tidal volume equal to 6 ml/kg PBW.
• Written consent from patient's next of kin

You may not qualify if:

• contra-indication to the prone position
• Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mm Hg
• Massive haemoptysis needing urgent surgical or radiological treatment
• Tracheal or thoracic surgery in the last 15 days
• Facial trauma or surgery in the last 15 days
• Deep venous thrombosis or pulmonary embolism treated in the last 2 days
• Cardiac pace maker implantation in the last 2 days
• Unstable bone dislocations of rachis, femur, rib cage, pelvis
• Mean systolic arterial pressure less than 70 mm Hg despite vasopressive therapy
• Pregnancy
• Bronchopleural fistula treated with a single anterior chest tube (risk of kinking in prone position)
• Necessity to use NOi or almitrine
• Extra body circulation for oxygenation and/or CO2 epuration
• Pulmonary transplantation
• Burns ≥ 20% of body surface

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Croix Rousse

Lyon, 69317, France

Location

Related Publications (2)

• 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: 23688302 RESULT

• Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.

  PMID: 27894328 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guerin Claude, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

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: September 10, 2007
• First Posted: September 11, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)