Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome (LOVS)
April 19, 2007 updated by: Hamilton Health Sciences Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
980
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 5G4
- Hamilton Health Sciences - General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Hospital Mortality
|
Secondary Outcome Measures
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maureen O Meade, MD, FRCPC, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mehta S, Cook DJ, Skrobik Y, Muscedere J, Martin CM, Stewart TE, Burry LD, Zhou Q, Meade M. A ventilator strategy combining low tidal volume ventilation, recruitment maneuvers, and high positive end-expiratory pressure does not increase sedative, opioid, or neuromuscular blocker use in adults with acute respiratory distress syndrome and may improve patient comfort. Ann Intensive Care. 2014 Nov 6;4:33. doi: 10.1186/s13613-014-0033-9. eCollection 2014.
- 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. doi: 10.1001/jama.299.6.637.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
April 23, 2007
Last Update Submitted That Met QC Criteria
April 19, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38141-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.