Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome (LOVS)
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ClinicalTrials.gov Identifier: NCT00182195 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome | Procedure: Control Ventilation Strategy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 980 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury |
Study Start Date : | August 2000 |
Actual Study Completion Date : | March 2006 |

- Hospital Mortality
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182195
Canada, Ontario | |
Hamilton Health Sciences - General Hospital | |
Hamilton, Ontario, Canada, L8L 5G4 |
Principal Investigator: | Maureen O Meade, MD, FRCPC | McMaster University |
ClinicalTrials.gov Identifier: | NCT00182195 |
Other Study ID Numbers: |
38141-1 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | April 23, 2007 |
Last Verified: | April 2007 |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Syndrome Disease Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |