Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 10:43 AM
Study NCT ID:
NCT00474656
Status:
COMPLETED
Last Update Posted:
2009-01-30
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006612', 'term': 'High-Frequency Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2007-05-15', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adherence to our explicit mechanical ventilation protocols;', 'timeFrame': 'duration of mechanical ventilation'}, {'measure': 'to measure and understand the reasons for crossovers between groups', 'timeFrame': 'duration of mechanical ventilation'}, {'measure': 'to estimate the rate of patient recruitment, and understand barriers to recruitment'}, {'measure': 'to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high frequency oscillation', 'lung-protective ventilation', 'ARDS', 'ventilator-induced lung injury'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '26192398', 'type': 'DERIVED', 'citation': 'Arabi YM, Cook DJ, Zhou Q, Smith O, Hand L, Turgeon AF, Matte A, Mehta S, Graham R, Brierley K, Adhikari NK, Meade MO, Ferguson ND; Canadian Critical Care Trials Group. Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1306-13. doi: 10.1164/rccm.201501-0172OC.'}, {'pmid': '23339639', 'type': 'DERIVED', 'citation': 'Ferguson ND, Cook DJ, Guyatt GH, Mehta S, Hand L, Austin P, Zhou Q, Matte A, Walter SD, Lamontagne F, Granton JT, Arabi YM, Arroliga AC, Stewart TE, Slutsky AS, Meade MO; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805. doi: 10.1056/NEJMoa1215554. Epub 2013 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex, 16 years and above;\n* Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;\n* Endotracheal intubation or tracheostomy;\n* Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;\n* Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph\n\nExclusion Criteria:\n\n* Remaining duration of mechanical ventilation \\< 48 hours, as judged by the attending physician;\n* Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;\n* Lack of commitment to ongoing life support;\n* Weight \\< 35 kg;\n* Severe chronic respiratory disease\n* Morbid obesity - defined as \\> 1 kg / cm body height;\n* Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);\n* Neuromuscular disease that will result in prolonged need for mechanical ventilation;\n* Previous enrolment in this trial;\n* All inclusion criteria present for \\> 72 hours;\n* On HFO at the time of screening.'}, 'identificationModule': {'nctId': 'NCT00474656', 'acronym': 'OSCILLATE', 'briefTitle': 'The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Critical Care Trials Group'}, 'officialTitle': 'The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study', 'orgStudyIdInfo': {'id': '164451'}}, 'armsInterventionsModule': {'interventions': [{'name': 'High-frequency oscillation', 'type': 'DEVICE'}, {'name': 'Conventional lung-open mechanical ventilation', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Medical Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Fahad National Guard Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Niall D Ferguson, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}, {'name': 'Maureen O Meade, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Critical Care Trials Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}]}}}