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OpenTrials
Completed

NCT Number: NCT00182195

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, L8L 5G4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Ventilation Strategy

Procedure

Primary outcomes

  1. Hospital Mortality

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: LOVS

Important dates

Study start
2000
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Apr 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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