This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Policlinico Hospital Identifier:
First received: September 7, 2005
Last updated: June 9, 2008
Last verified: June 2008
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 Intervention Phase
ARDS, Human Procedure: prone positioning Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Policlinico Hospital:

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

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

Enrollment: 344
Study Start Date: February 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: prone position
prone positioning
Procedure: prone positioning
prone positioning
No Intervention: supine position

  Show Detailed Description


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: September 7, 2005
Last Updated: June 9, 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 processed this record on August 23, 2017