Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT03056820
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Apnea Tolerance in Two Positions of Patients With BMI 30-40
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The person measuring and recording the study data will be blinded.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerable Apnea Time (TAT)', 'timeFrame': 'Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes', 'description': "Measure of the TAT between groups to determine if the TAT is a function of the participant's position."}], 'secondaryOutcomes': [{'measure': 'Length of time to intubation (TTI)', 'timeFrame': 'Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes'}, {'measure': 'Peripheral arterial hemoglobin oxygen saturation (SpO2) trough', 'timeFrame': 'Time until SpO2 decreased to 92%, up to 8 minutes', 'description': 'Measure of the rebound SpO2. It is the lowest SpO2 reading reached subsequent to start of mechanical ventilation at the SpO2 value of 94% and it represents final completion of SpO2 decline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheal intubation'], 'conditions': ['General Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apnea time (TAT) after induction of general anesthesia in patients with a body mass index (BMI) of 30-40.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Body Mass Index (BMI) of 30-40\n* Scheduled for an elective surgery that requires tracheal intubation\n\nExclusion Criteria:\n\n* Patients with abnormalities of the upper airway that require awake tracheal intubation\n* Asthma\n* Chronic obstructive pulmonary disease\n* Congestive heart failure\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT03056820', 'briefTitle': 'Comparison of Apnea Tolerance in Two Positions of Patients With BMI 30-40', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Comparison of Apnea Tolerance in Two Positions of Patients With Body Mass Index (BMI) 30-40', 'orgStudyIdInfo': {'id': '12197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A - 25° head-up position', 'description': 'Participants will be positioned at 25° angle for procedure.', 'interventionNames': ['Other: 25° head-up position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B - 55° head-up position', 'description': 'Participants will be positioned at 55° angle for procedure.', 'interventionNames': ['Other: 55° head-up position']}], 'interventions': [{'name': '25° head-up position', 'type': 'OTHER', 'description': 'Participant will be positioned at 25° angle for procedure.', 'armGroupLabels': ['A - 25° head-up position']}, {'name': '55° head-up position', 'type': 'OTHER', 'description': 'Participant will be positioned at 55° angle for procedure.', 'armGroupLabels': ['B - 55° head-up position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Mirsad Dupanović, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}