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

This study has been completed.
Sponsor:
Information provided by:
Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00159939
First received: September 7, 2005
Last updated: June 9, 2008
Last verified: June 2008
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator-free days [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
  • Number of days without respiratory failure [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
  • Number of days of dysfunction for each organ system and cumulative dysfunction (sequential organ failure assessment [SOFA] score) [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
  • 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00159939

Locations
Italy
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 "Sacco"
Milan, Italy
Humanitas
Milan, Italy
Hospital "S.Paolo"
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
Investigators
Study Director: Luciano Gattinoni, MD, FRCP Policlinico Hospital of Milan
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luciano Gattinoni, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00159939     History of Changes
Other Study ID Numbers: 392
Study First Received: September 7, 2005
Last Updated: June 9, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
ARDS
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

ClinicalTrials.gov processed this record on October 01, 2014