Condition category
Respiratory
Date applied
11/08/2005
Date assigned
11/08/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18270352

Publication citations

  1. 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.

Additional files

Editorial Notes