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

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

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 Submitted: September 12, 2005
First Posted: September 16, 2005
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