Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-04 @ 4:45 AM
Study NCT ID:
NCT01957566
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2013-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-09-30', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event', 'timeFrame': 'Day 1 of propofol sedation.'}, {'measure': 'A stridor score of less than 2 will be defined as not sedation-related event.', 'timeFrame': 'Day 1 of sedation.'}], 'secondaryOutcomes': [{'measure': 'The positive predictive value and negative predictive value of the APS for predicting airway obstruction.', 'timeFrame': 'Day 1 of propofol sedation.', 'description': 'A subject will be considered as evaluable for the sensitivity/specificity evaluation if (1) all inclusion criteria are met, (2) presedation phase is completed, and (3) the sedation induction and maintenance phase is completed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['propofol sedation', 'children', 'procedure sedation'], 'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the American Family Children's Hospital (AFCH) Pediatric Sedation Clinic\n* American Society of Anesthesiology score (ASA) of 1-2\n\nExclusion Criteria:\n\n* ASA scoring \\> 3\n* Oxygen requirement and cardiorespiratory instability\n* Allergy to propofol or its components\n* Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic"}, 'identificationModule': {'nctId': 'NCT01957566', 'briefTitle': 'The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study', 'orgStudyIdInfo': {'id': 'HSC 2012-0259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APS', 'interventionNames': ['Procedure: APS']}], 'interventions': [{'name': 'APS', 'type': 'PROCEDURE', 'armGroupLabels': ['APS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "American Family Children's Hospital (AFCH)", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Juan Boriosi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}