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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Control Ventilation Strategy
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences - General Hospital

Outcomes

Primary Outcome Measures

Hospital Mortality

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
April 19, 2007
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00182195
Brief Title
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
Acronym
LOVS
Official Title
A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
980 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Control Ventilation Strategy
Primary Outcome Measure Information:
Title
Hospital Mortality
Secondary Outcome Measure Information:
Title
Mortality attributed to respiratory failure
Title
Duration of respiratory failure and duration of mechanical failure
Title
Evaluation of respiratory function during mechanical ventilation
Title
Incidence of barotraumas
Title
Non-respiratory organ dysfunction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen O Meade, MD, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences - General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25593749
Citation
Mehta S, Cook DJ, Skrobik Y, Muscedere J, Martin CM, Stewart TE, Burry LD, Zhou Q, Meade M. A ventilator strategy combining low tidal volume ventilation, recruitment maneuvers, and high positive end-expiratory pressure does not increase sedative, opioid, or neuromuscular blocker use in adults with acute respiratory distress syndrome and may improve patient comfort. Ann Intensive Care. 2014 Nov 6;4:33. doi: 10.1186/s13613-014-0033-9. eCollection 2014.
Results Reference
derived
PubMed Identifier
18270352
Citation
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; Lung Open Ventilation Study Investigators. 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 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.
Results Reference
derived

Learn more about this trial

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

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