Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02184702
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-08', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Direct intracuff pressure measurement technique using manometer', 'timeFrame': 'every one hour during operarion'}]}, 'conditionsModule': {'conditions': ['Arthroscopy']}, 'descriptionModule': {'briefSummary': 'Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) 1,2 Age 20-65\n\nExclusion Criteria:\n\n* emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection'}, 'identificationModule': {'nctId': 'NCT02184702', 'briefTitle': 'Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'orgStudyIdInfo': {'id': 'IIT-2014-192'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'shoulder arthroscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100-032', 'city': 'Seoul', 'state': 'Jung-Gu', 'country': 'South Korea', 'facility': 'Inje University Seoul Paik Hospital, Seoul, Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sira Bang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University Seoul Paik Hospital, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Kabi Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sira Bang', 'investigatorAffiliation': 'Inje University'}}}}