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

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00182195
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 980
• Location: 1
• Duration (Months): 67
• Patients Per Site Per Month: 14.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Procedure: Control Ventilation Strategy	Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
• Study Start Date: Aug 1, 2000
• Actual Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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 barotraumas []

5. Non-respiratory organ dysfunction []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences - General Hospital	Hamilton	Ontario	Canada	L8L 5G4

Sponsors and Collaborators

• Hamilton Health Sciences Corporation
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Maureen O Meade, MD, FRCPC, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00182195
• Other Study ID Numbers: 38141-1
• First Posted: Sep 16, 2005
• Last Update Posted: Apr 23, 2007
• Last Verified: Apr 1, 2007

• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome

Study Results

No Results Posted as of Apr 23, 2007