Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT01235650
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of inadvertent hyperventilation', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation.', 'detailedDescription': 'Retrospective review of the operative schedules to identify patients who have undergone spinal fusion with placement of an arterial cannula for intermittent arterial blood gas analysis. The intraoperative records will be retrospectively reviewed. The following demographic data will be recorded: age, weight, gender, and co-morbid medical conditions. Ventilatory parameters at the time of ABG analysis will include (respiratory rate and tidal volume). ABG data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal fusion patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01235650', 'briefTitle': 'Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care', 'orgStudyIdInfo': {'id': 'IRB10-00390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal fusion', 'description': 'Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}