Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-13 @ 12:41 PM
Study NCT ID:
NCT02764632
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitation of NGT Insertion
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-08', 'studyFirstSubmitDate': '2016-05-05', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NGT insertion success rate', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nasogasrtic Tube Insertion']}, 'descriptionModule': {'briefSummary': 'Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing experience. Many techniques have been explained to improve success rate along with increasing safety, such as forward displacement of the larynx, tube rigidity improvement methods, pushing it down directly through pharynx or using a guide tube. Failure of insertion under general anesthesia reached 50% in some publications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all surgicl patients needing NGT insertion\n\nExclusion Criteria:\n\n* refusal coagulopathy ASA more than 2'}, 'identificationModule': {'nctId': 'NCT02764632', 'acronym': 'NGT', 'briefTitle': 'Facilitation of NGT Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Digital Facilitation of Nasogastric Tube Insertion Under General Anethesia', 'orgStudyIdInfo': {'id': 'RefaNGT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Didgital group', 'description': 'After induction of anesthesia, and after ensuring muscle relaxation, NGT will be inserted through the selected nostril and advanced for 12 cm then the NGT was advanced according to study group advancing. In control group; NGT was inserted with patient head flexed. In D group, after feeling the NGT in pharynx, with the head in neutral position,the index finger was used to support the NGT with slight direction towards the left side. This will prevent tube kinking at this point in front of the resistance offered by the inflated tube cuff or arytenoids cartilage. Also, this digital support reinforces the tube at the area weakened by its openings', 'interventionNames': ['Procedure: Digital facilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Digital facilitation', 'type': 'PROCEDURE', 'armGroupLabels': ['Didgital group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dkahleya', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}