A randomised trial of a Lung-Open Ventilation Strategy in acute lung injury
ISRCTN | ISRCTN61546997 |
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DOI | https://doi.org/10.1186/ISRCTN61546997 |
ClinicalTrials.gov number | NCT00182195 |
Secondary identifying numbers | MCT-38141 |
- Submission date
- 11/08/2005
- Registration date
- 11/08/2005
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maureen Ora Meade
Scientific
Scientific
Clinical Epidemiology & Biostatistics
McMaster University
Health Sciences Centre
Room 2C10
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
Phone | +1 905 525 9140 (22900) |
---|---|
meadema@hhsc.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | LOVS |
Study objectives | The Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay. |
Ethics approval(s) | The Hamilton Health Sciences/McMaster University Research Ethics Board, 15/06/2004 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/08/2000 |
Completion date | 31/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 980 |
Key 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) |
Key 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 |
Date of first enrolment | 01/08/2000 |
Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Clinical Epidemiology & Biostatistics
Hamilton, Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
Phone | +1 905 525 9140 |
---|---|
browna@mcmaster.ca | |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38141)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 13/02/2008 | Yes | No |