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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182195
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2007
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

September 12, 2005
September 16, 2005
April 23, 2007
August 2000
Not Provided
Hospital Mortality
Same as current
Complete list of historical versions of study NCT00182195 on 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
Same as current
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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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Procedure: Control Ventilation Strategy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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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