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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182195
First received: September 12, 2005
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Respiratory Distress Syndrome
 Procedure: Control Ventilation Strategy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury

Further study details as provided by McMaster University:

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

Estimated Enrollment: 980
Study Start Date: August 2000
Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182195

Locations
Canada, Ontario
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
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00182195     History of Changes
Other Study ID Numbers: 38141-1
Study First Received: September 12, 2005
Last Updated: April 19, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 22, 2013