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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | April 19, 2007 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Hospital Mortality | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00182195 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome | ||||
| Official Title ICMJE | A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury | ||||
| Brief Summary | A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Acute Respiratory Distress Syndrome | ||||
| Intervention ICMJE | Procedure: Control Ventilation Strategy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 980 | ||||
| Completion Date | March 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00182195 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 38141-1 | ||||
| Study Sponsor ICMJE | Hamilton Health Sciences | ||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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