A randomised trial of a Lung-Open Ventilation Strategy in acute lung injury

ISRCTN ISRCTN61546997
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

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)
Email meadema@hhsc.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymLOVS
Study objectivesThe 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) studiedCritically Ill Patients with Acute Lung Injury (ALI)
InterventionControl 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 typeOther
Primary outcome measureHospital Mortality
Secondary outcome measures1. 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 date01/08/2000
Completion date31/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants980
Key inclusion criteriaPersons 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 criteria1. 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 enrolment01/08/2000
Date of final enrolment31/01/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

Clinical Epidemiology & Biostatistics
Hamilton, Ontario
L8N 3Z5
Canada

Sponsor information

McMaster University (Canada)
University/education

1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Phone +1 905 525 9140
Email browna@mcmaster.ca
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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