Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159939
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 11, 2008
Information provided by:
Policlinico Hospital

Brief Summary:
The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).

Condition or disease Intervention/treatment Phase
ARDS, Human Procedure: prone positioning Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Study Start Date : February 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Active Comparator: prone position
prone positioning
Procedure: prone positioning
prone positioning

No Intervention: supine position

Primary Outcome Measures :
  1. Mortality [ Time Frame: at 28 days ]

Secondary Outcome Measures :
  1. Ventilator-free days [ Time Frame: ICU discharge ]
  2. Number of days without respiratory failure [ Time Frame: ICU discharge ]
  3. Number of days of dysfunction for each organ system and cumulative dysfunction (sequential organ failure assessment [SOFA] score) [ Time Frame: ICU discharge ]
  4. Mortality [ Time Frame: at ICU discharge, at 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients receiving mechanical ventilation will be enrolled if they meet criteria for acute respiratory distress syndrome, with the PaO2/FiO2 ratio criterion modified as follows:

    • PaO2/FiO2 ratio ≤ 200 with 5 ≤ PEEP ≤ 10 cmH2O

Exclusion Criteria:

  • Age < 16 years.
  • > 72 hours since all inclusion criteria are met.
  • Lung transplant, liver transplant or bone marrow transplant.
  • Clinical or instrumental evidence of cerebral edema or elevated endocranial pressure.
  • Conditions which are thought to contraindicate the use of prone positioning (i.e., not-stabilized bone fracture, column fracture, pelvis fracture, multiple rib fracture with chest-wall instability, severe haemodynamic instability).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159939

Hospital "Ospedali Riuniti di Bergamo"
Bergamo, Italy
Hospital "Ospedale Maggiore di Bologna"
Bologna, Italy
Hospital "di Circolo"
Busto Arsizio, Italy
Hospital "A.Uboldo"
Cernusco sul Naviglio, Italy
Hospital "di Circolo"
Desio, Italy
Hospital "S.Martino"
Genova, Italy
Hospital "Civile di Legnano"
Legnano, Italy
Hospital "S.Paolo"
Milan, Italy
Hospital "Sacco"
Milan, Italy
Milan, Italy
Policlinico Hospital
Milan, Italy
Hospital "S.Gerardo"
Monza, Italy
Hospital of Padova
Padova, Italy
Policlinico "S.Matteo"
Pavia, Italy
Hospital "Caravaggio"
Treviglio, Italy
Hospital "S.Bortolo"
Vicenza, Italy
Hospital "Ospedale Civile"
Vimercate, Italy
Sponsors and Collaborators
Policlinico Hospital
Study Director: Luciano Gattinoni, MD, FRCP Policlinico Hospital of Milan

Gattinoni L, Pelosi P, Valenza F, Mascheroni D. Patient positioning in acute respiratory failure. Chapter 47 in: Principles and practice of mechanical ventilation. Ed.: Tobin MJ, Illinois, USA.
Mancebo J, Rialp G, Fernandez R, Gordo F, Albert RK. Prone vs supine position in ARDS patients. Results of a randomized multicenter trial. Am J Respir Crit Care Med 2003; 167: A180.
Guidelines for Good Clinical Practice, par. 4.8. ICH Steering Committee meeting. 1 May 1996.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Luciano Gattinoni, Policlinico Hospital Identifier: NCT00159939     History of Changes
Other Study ID Numbers: 392
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by Policlinico Hospital:
prone position

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury