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

This study has been completed.

Sponsor:

Collaborator:

Canadian Institutes of Health Research (CIHR)

Information provided by:

McMaster University

ClinicalTrials.gov Identifier:

NCT00182195

First received: September 12, 2005

Last updated: April 19, 2007

Last verified: April 2007

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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: NCT00182195

Locations


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

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Canadian Institutes of Health Research (CIHR)

Investigators


Principal Investigator:	Maureen O Meade, MD, FRCPC	McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1001/jama.299.6.637.


ClinicalTrials.gov Identifier:	NCT00182195 History of Changes
Other Study ID Numbers:	38141-1
Study First Received:	September 12, 2005
Last Updated:	April 19, 2007
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:


Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Disease Pathologic Processes	Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury

ClinicalTrials.gov processed this record on September 26, 2016

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