Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 9:57 AM
Study NCT ID:
NCT01086995
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2010-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning And Variability Evaluation (WAVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2010-03-12', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous heart rate and respiratory rate waveforms', 'timeFrame': 'at time of sponataneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['extubation', 'weaning', 'mechanical ventilation'], 'conditions': ['Extubation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned.', 'detailedDescription': "In this prospective observational pilot study, mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) were selected to undergo continuous heart rate (EKG waveform at 500 Hz) and respiratory rate (expired CO2 waveform at 100 Hz) recording. The data was collected as per standard practice by the bedside monitor (Phillips Intelivue MP70). A portable CPU with TrendfaceTM software was used to download the data for variability analysis. All decisions on timing of SBTs and extubation were left to the discretion of the treating team who were unaware of the variability results. SBT's were repeated daily from trial onset until extubation patient permitting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been requiring mechanical ventilation for \\>48 hours.\n* At least partial reversal of the condition precipitating invasive ventilation.\n* Stabilization of "other" organ system failures (i.e. no worsening).\n* The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O)\n* The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors).\n* Stable neurological status (no deterioration in the last 24 hors, intact respiratory drive and ICP \\< 20).\n* The patient has intact airway reflexes (adequate cough with suctioning and a gag reflex).\n\nExclusion Criteria:\n\n* Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis).\n* Do not reintubate order documented on chart or anticipated withdrawal of life support.\n* Tracheostomy\n* Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia.\n* Severe heart failure or Grade IV left ventricular function.\n* Prior extubation during ICU stay.'}, 'identificationModule': {'nctId': 'NCT01086995', 'acronym': 'WAVE', 'briefTitle': 'Weaning And Variability Evaluation (WAVE)', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Weaning And Variability Evaluation', 'orgStudyIdInfo': {'id': 'OH2007-588'}}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Andrew Seely, MD, PhD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}