Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome - Tabular View

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Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome (LOVS)

This study has been completed.

Study NCT00182195. Last updated on April 19, 2007. Information provided by McMaster University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome

Official Title ^†

A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

Brief Summary

A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.

Detailed Description

To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Hospital Mortality

Secondary Outcome Measure ^†

Mortality attributed to respiratory failure
Duration of respiratory failure and duration of mechanical failure
Evaluation of respiratory function during mechanical ventilation
Incidence of barotraumas
Non-respiratory organ dysfunction

Condition ^†

Acute Respiratory Distress Syndrome

Intervention ^†

Procedure: Control Ventilation Strategy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

980

Start Date ^†

August 2000

Completion Date

March 2006

Eligibility Criteria ^†

Inclusion Criteria:

Invasive mechanical ventilation
Acute respiratory insufficiency (within past 28 days)
Bilateral infiltrates on frontal chest radiograph
Hypoxemia, defined as PaO2/FiO2<=250

Exclusion Criteria:

Primary cause of respiratory failure is cardiac
Anticipated duration of mechanical ventilation < 48 hours
Inability to wean other experimental ventilation strategies
Severe chronic respiratory disease
Neuromuscular disease that will prolong mechanical ventilation
Conditions where hypercapnia-induced intracranial hypertension should be avoided
Morbid obesity (> 1Kg per cm body weight)
Pregnancy
Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality >= 50%
Greater than 48 hours elapsed since first eligible
Current participation in competing trial
Lack of physician, patient or proxy consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Administrative Information Fields

NCT ID ^†

NCT00182195

Organization ID

38141-1

Secondary IDs ^††

Study Sponsor ^†

Hamilton Health Sciences

Collaborators ^††

Canadian Institutes of Health Research (CIHR)

Investigators ^†

Principal Investigator:

Maureen O Meade, MD, FRCPC

McMaster University

Information Provided By

McMaster University

Verification Date

April 2007

First Received Date ^†

September 12, 2005

Last Updated Date

April 19, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.