Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-01-14 @ 4:09 PM
Study NCT ID:
NCT00182195
Status:
COMPLETED
Last Update Posted:
2007-04-23
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Mortality'}], 'secondaryOutcomes': [{'measure': 'Mortality attributed to respiratory failure'}, {'measure': 'Duration of respiratory failure and duration of mechanical failure'}, {'measure': 'Evaluation of respiratory function during mechanical ventilation'}, {'measure': 'Incidence of barotraumas'}, {'measure': 'Non-respiratory organ dysfunction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '25593749', 'type': 'DERIVED', 'citation': 'Mehta S, Cook DJ, Skrobik Y, Muscedere J, Martin CM, Stewart TE, Burry LD, Zhou Q, Meade M. A ventilator strategy combining low tidal volume ventilation, recruitment maneuvers, and high positive end-expiratory pressure does not increase sedative, opioid, or neuromuscular blocker use in adults with acute respiratory distress syndrome and may improve patient comfort. Ann Intensive Care. 2014 Nov 6;4:33. doi: 10.1186/s13613-014-0033-9. eCollection 2014.'}, {'pmid': '18270352', 'type': 'DERIVED', 'citation': '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. doi: 10.1001/jama.299.6.637.'}]}, 'descriptionModule': {'briefSummary': 'A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive mechanical ventilation\n* Acute respiratory insufficiency (within past 28 days)\n* Bilateral infiltrates on frontal chest radiograph\n* Hypoxemia, defined as PaO2/FiO2\\<=250\n\nExclusion Criteria:\n\n* Primary cause of respiratory failure is cardiac\n* Anticipated duration of mechanical ventilation \\< 48 hours\n* Inability to wean other experimental ventilation strategies\n* Severe chronic respiratory disease\n* Neuromuscular disease that will prolong mechanical ventilation\n* Conditions where hypercapnia-induced intracranial hypertension should be avoided\n* Morbid obesity (\\> 1Kg per cm body weight)\n* Pregnancy\n* Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality \\>= 50%\n* Greater than 48 hours elapsed since first eligible\n* Current participation in competing trial\n* Lack of physician, patient or proxy consent'}, 'identificationModule': {'nctId': 'NCT00182195', 'acronym': 'LOVS', 'briefTitle': 'Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury', 'orgStudyIdInfo': {'id': '38141-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Control Ventilation Strategy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 5G4', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences - General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Maureen O Meade, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}]}}}