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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

September 12, 2005
April 19, 2007
August 2000
Not Provided
Hospital Mortality
Same as current
Complete list of historical versions of study NCT00182195 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Procedure: Control Ventilation Strategy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
980
March 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182195
38141-1
Yes
Not Provided
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Maureen O Meade, MD, FRCPC McMaster University
McMaster University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP