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

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

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

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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

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
Humanitas
Milan, Italy
Hospital "S.Paolo"
Milan, Italy
Policlinico Hospital
Milan, Italy
Hospital "Sacco"
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:

Gattinoni L, Pelosi P, Vitale G, Pesenti A, D'Andrea L, Mascheroni D. Body position changes redistribute lung computed-tomographic density in patients with acute respiratory failure. Anesthesiology. 1991 Jan;74(1):15-23.

Pelosi P, Tubiolo D, Mascheroni D, Vicardi P, Crotti S, Valenza F, Gattinoni L. Effects of the prone position on respiratory mechanics and gas exchange during acute lung injury. Am J Respir Crit Care Med. 1998 Feb;157(2):387-93.

Langer M, Mascheroni D, Marcolin R, Gattinoni L. The prone position in ARDS patients. A clinical study. Chest. 1988 Jul;94(1):103-7.

Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R; Prone-Supine Study Group. Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med. 2001 Aug 23;345(8):568-73. Summary for patients in: Aust J Physiother. 2002;48(3):237.

Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. Review.

[No authors listed] Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8.

Geller NL, Pocock SJ. Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics. 1987 Mar;43(1):213-23.

Gattinoni L, Brazzi L, Pelosi P, Latini R, Tognoni G, Pesenti A, Fumagalli R. A trial of goal-oriented hemodynamic therapy in critically ill patients. SvO2 Collaborative Group. N Engl J Med. 1995 Oct 19;333(16):1025-32.

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):

Taccone P, Pesenti A, Latini R, Polli F, Vagginelli F, Mietto C, Caspani L, Raimondi F, Bordone G, Iapichino G, Mancebo J, Guérin C, Ayzac L, Blanch L, Fumagalli R, Tognoni G, Gattinoni L; Prone-Supine II Study Group. Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2009 Nov 11;302(18):1977-84.

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 June 18, 2013