Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT01783366
Status:
UNKNOWN
Last Update Posted:
2013-02-05
First Post:
2013-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-03', 'studyFirstSubmitDate': '2013-01-24', 'studyFirstSubmitQcDate': '2013-01-31', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of attempt of NGT insertion', 'timeFrame': 'after successful insertion of NGT, within 1 hr', 'description': 'After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed.\n\nThus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT.'}, {'measure': 'Procedure time of NGT insertion', 'timeFrame': 'after successful insertion of NGT, within 1 hr', 'description': 'After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT.'}], 'secondaryOutcomes': [{'measure': 'presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view', 'timeFrame': 'after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours', 'description': 'The investigators examined the occurrence of complication associated with NGT insertion. After successful NGT insertion, we recorded presence of bleeding of the larynx, and knotting or kinking of NGT using laryngoscopy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nasogastric tube, tube exchange catheter'], 'conditions': ['Elective Surgery of Gastrointestinal Tract', '100 Adults Aged Between 20 and 70 Years Old', 'ASA Physical Status of I or II']}, 'descriptionModule': {'briefSummary': 'we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. We then addressed the question of whether the use of tube exchange catheter might decrease the possible occurrence of complication associated with YOON insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled\n\nExclusion Criteria:\n\n* Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01783366', 'briefTitle': 'Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': 'Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients', 'orgStudyIdInfo': {'id': 'PNU03-2013-002'}, 'secondaryIdInfos': [{'id': 'PNUYH03-2013-002', 'type': 'OTHER', 'domain': 'PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tube-exchanger', 'description': 'The tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, \\[cook medical, Bloomington, IN\\]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT', 'interventionNames': ['Device: TUBE EXCHANGER']}], 'interventions': [{'name': 'TUBE EXCHANGER', 'type': 'DEVICE', 'otherNames': ['TUBE EXCHANGER USAGE'], 'armGroupLabels': ['tube-exchanger']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yangsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JI WOOK YOON, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pnuyh Anesthesia', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'HYEON-JEONG LEE, PhD', 'role': 'CONTACT', 'email': 'lhjksk@pusan.ac.kr', 'phone': '82-10-76807689'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'Hyeon-Jeong Lee', 'investigatorAffiliation': 'Pusan National University Hospital'}}}}