Contact information
Type
Scientific
Primary contact
Dr Maureen Ora Meade
ORCID ID
Contact details
Clinical Epidemiology & Biostatistics
McMaster University
Health Sciences Centre
Room 2C10
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 (22900)
meadema@hhsc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182195
Protocol/serial number
MCT-38141
Study information
Scientific title
Acronym
LOVS
Study hypothesis
The Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.
Ethics approval
The Hamilton Health Sciences/McMaster University Research Ethics Board, 15/06/2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Critically Ill Patients with Acute Lung Injury (ALI)
Intervention
Control Ventilation Strategy (assist control; low tidal volume; low airway pressures; standard PEEP)
Experimental Lung Open Ventilation Strategy (pressure control; low tidal volumes; low airway pressures; high PEEP; recruitment maneuvers).
For further information, please contact Dr Meade at the address listed below or Dr Thomas Stewart at University of Toronto (tstewart@mtsinai.on.ca).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 barotrauma
5. Non-respiratory organ dysfunction
Overall trial start date
01/08/2000
Overall trial end date
31/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Persons of either sex 18 years and older.
1. Invasive mechanical ventilation
2. Acute respiratory insufficiency (within past 28 days)
3. Bilateral infiltrates on frontal chest radiograph
4. Hypoxemia, defined as paO2/FiO2 less than or equal to 250, on any amount of Positive End-Expiratory Pressure (PEEP)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
980
Participant exclusion criteria
1. Primary cause of respiratory failure is cardiac
2. Anticipated duration of mechanical ventilation <48 hours, as judged by the intensivist
3. Inability to wean from other experimental ventilation strategies
4. Severe chronic respiratory disease
5. Neuromuscular disease that will result in prolonged need for mechanical ventilation
6. Conditions where hypercapnia-induced intracranial hypertension should be avoided
7. Morbid obesity (>1 kg per cm body weight)
8. Pregnancy
9. Very unlikely to survive in the judgment of the investigator, and luck of commitment to life support
10. Malignancy or underlying irreversible condition with 6 month mortality greater than or equal to 50%
11. Greater than 48 hours elapsed since first eligible in study hospital
12. Current participation in competing trial
13. Lack of physician, patient or proxy consent
Recruitment start date
01/08/2000
Recruitment end date
31/01/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Clinical Epidemiology & Biostatistics
Hamilton, Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140
browna@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38141)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18270352
Publication citations
-
Results
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, , 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, 299, 6, 637-645, doi: 10.1001/jama.299.6.637.