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

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ClinicalTrials.gov Identifier: NCT00182195
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2007
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

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

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Procedure: Control Ventilation Strategy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Study Start Date : August 2000
Actual Study Completion Date : March 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Hospital Mortality

Secondary Outcome Measures :
  1. Mortality attributed to respiratory failure
  2. Duration of respiratory failure and duration of mechanical failure
  3. Evaluation of respiratory function during mechanical ventilation
  4. Incidence of barotraumas
  5. Non-respiratory organ dysfunction

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00182195     History of Changes
Other Study ID Numbers: 38141-1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 23, 2007
Last Verified: April 2007

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