NCT00159939

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2004

Typical duration for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

4.3 years

First QC Date

September 7, 2005

Last Update Submit

June 9, 2008

Conditions

ARDS, Human

Keywords

ARDSprone position

Outcome Measures

Primary Outcomes (1)

  • Mortality

    at 28 days

Secondary Outcomes (4)

  • Ventilator-free days

    ICU discharge

  • Number of days without respiratory failure

    ICU discharge

  • Number of days of dysfunction for each organ system and cumulative dysfunction (sequential organ failure assessment [SOFA] score)

    ICU discharge

  • Mortality

    at ICU discharge, at 6 months

Study Arms (2)

prone position

ACTIVE COMPARATOR

prone positioning

Procedure: prone positioning

supine position

NO INTERVENTION

Interventions

prone positioningPROCEDURE

prone positioning

prone position

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 16 years.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospital "Ospedali Riuniti di Bergamo"

Bergamo, Italy

Location

Hospital "Ospedale Maggiore di Bologna"

Bologna, Italy

Location

Hospital "di Circolo"

Busto Arsizio, Italy

Location

Hospital "A.Uboldo"

Cernusco sul Naviglio, Italy

Location

Hospital "di Circolo"

Desio, Italy

Location

Hospital "S.Martino"

Genova, Italy

Location

Hospital "Civile di Legnano"

Legnano, Italy

Location

Hospital "S.Paolo"

Milan, Italy

Location

Hospital "Sacco"

Milan, Italy

Location

Humanitas

Milan, Italy

Location

Policlinico Hospital

Milan, Italy

Location

Hospital "S.Gerardo"

Monza, Italy

Location

Hospital of Padova

Padua, Italy

Location

Policlinico "S.Matteo"

Pavia, Italy

Location

Hospital "Caravaggio"

Treviglio, Italy

Location

Hospital "S.Bortolo"

Vicenza, Italy

Location

Hospital "Ospedale Civile"

Vimercate, Italy

Location

Related Publications (12)

  • 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. doi: 10.1097/00000542-199101000-00004.

    PMID: 1986640BACKGROUND

  • 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. doi: 10.1164/ajrccm.157.2.97-04023.

    PMID: 9476848BACKGROUND

  • Langer M, Mascheroni D, Marcolin R, Gattinoni L. The prone position in ARDS patients. A clinical study. Chest. 1988 Jul;94(1):103-7. doi: 10.1378/chest.94.1.103.

    PMID: 3383620BACKGROUND

  • 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. doi: 10.1056/NEJMoa010043.

    PMID: 11529210BACKGROUND

  • 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. doi: 10.1164/ajrccm.149.3.7509706.

    PMID: 7509706BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

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

    PMID: 3567306BACKGROUND

  • 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. doi: 10.1056/NEJM199510193331601.

    PMID: 7675044BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Guidelines for Good Clinical Practice, par. 4.8. ICH Steering Committee meeting. 1 May 1996.

    BACKGROUND

  • Taccone P, Pesenti A, Latini R, Polli F, Vagginelli F, Mietto C, Caspani L, Raimondi F, Bordone G, Iapichino G, Mancebo J, Guerin 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. doi: 10.1001/jama.2009.1614.

    PMID: 19903918DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luciano Gattinoni, MD, FRCP

    Policlinico Hospital of Milan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 11, 2008

Record last verified: 2008-06

Locations

IT(17)