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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

Clinical Epidemiology & Biostatistics

Hamilton, Ontario
L8N 3Z5
Canada

McMaster University (Canada)
University/education

1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38141)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	13/02/2008		Yes	No