Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome - Full Text View

Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome (LOVS)

This study has been completed.

Sponsors and Collaborators:	Hamilton Health Sciences Canadian Institutes of Health Research (CIHR)
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182195

Purpose

A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.

Condition	Intervention	Phase
Acute Respiratory Distress Syndrome	Procedure: Control Ventilation Strategy	Phase III

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:

A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

Further study details as provided by McMaster University:

Primary Outcome Measures:

Hospital Mortality

Secondary Outcome Measures:

Mortality attributed to respiratory failure
Duration of respiratory failure and duration of mechanical failure
Evaluation of respiratory function during mechanical ventilation
Incidence of barotraumas
Non-respiratory organ dysfunction

Estimated Enrollment:

980

Study Start Date:

August 2000

Study Completion Date:

March 2006

Detailed Description:

To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

Invasive mechanical ventilation
Acute respiratory insufficiency (within past 28 days)
Bilateral infiltrates on frontal chest radiograph
Hypoxemia, defined as PaO2/FiO2<=250

Exclusion Criteria:

Primary cause of respiratory failure is cardiac
Anticipated duration of mechanical ventilation < 48 hours
Inability to wean other experimental ventilation strategies
Severe chronic respiratory disease
Neuromuscular disease that will prolong mechanical ventilation
Conditions where hypercapnia-induced intracranial hypertension should be avoided
Morbid obesity (> 1Kg per cm body weight)
Pregnancy
Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality >= 50%
Greater than 48 hours elapsed since first eligible
Current participation in competing trial
Lack of physician, patient or proxy consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182195

Locations

Canada, Ontario
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada, L8L 5G4

Sponsors and Collaborators

Hamilton Health Sciences

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Maureen O Meade, MD, FRCPC

McMaster University

More Information

Publications indexed to this study:

Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45.

Study ID Numbers:

38141-1

First Received:

September 12, 2005

Last Updated:

April 19, 2007

ClinicalTrials.gov Identifier:

NCT00182195

Health Authority:

Canada: Health Canada

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 07, 2009