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

H

Hamilton Health Sciences (HHS)

Status and phase

Completed
Phase 3

Conditions

Acute Respiratory Distress Syndrome

Treatments

Procedure: Control Ventilation Strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT00182195
38141-1

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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