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

Acute Respiratory Distress Syndrome Clinical Trial

— LOVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182195
• Other study ID #: 38141-1
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 19, 2007
• Start date: August 2000
• Est. completion date: March 2006

Study information

• Verified date: April 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Control Ventilation Strategy

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality
Secondary	Mortality attributed to respiratory failure
Secondary	Duration of respiratory failure and duration of mechanical failure
Secondary	Evaluation of respiratory function during mechanical ventilation
Secondary	Incidence of barotraumas
Secondary	Non-respiratory organ dysfunction