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

This study has been completed.
Study NCT00182195.   Last updated on April 19, 2007.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title  Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
Official Title  A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Brief Summary

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

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Hospital Mortality
Secondary Outcome Measure  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
Condition  Acute Respiratory Distress Syndrome
Intervention  Procedure: Control Ventilation Strategy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  980
Start Date  August 2000
Completion Date March 2006
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00182195
Organization ID 38141-1
Secondary IDs ††
Study Sponsor  Hamilton Health Sciences
Collaborators †† Canadian Institutes of Health Research (CIHR)
Investigators 
Principal Investigator:     Maureen O Meade, MD, FRCPC     McMaster University    
Information Provided By McMaster University
Verification Date April 2007
First Received Date  September 12, 2005
Last Updated Date April 19, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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