Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 9:03 PM
Study NCT ID:
NCT03141294
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Force(newton)', 'timeFrame': "Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)", 'description': 'Force refers to the force needed to dilate the airway and measured by force gauge'}], 'secondaryOutcomes': [{'measure': 'Time(seconds)', 'timeFrame': 'Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime', 'description': 'Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheostomy，fascia，force gauge'], 'conditions': ['Respiratory Failure', 'Respiratory Depression']}, 'referencesModule': {'references': [{'pmid': '25946970', 'type': 'RESULT', 'citation': 'Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients', 'detailedDescription': "Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years;\n* requirement for long-term mechanical ventilation;\n* failure of weaning from mechanical ventilation.\n\nExclusion Criteria:\n\n* age \\<18 years;\n* pre-existing infection at the tracheostomy site;\n* pre-existing malignancy at the tracheostomy site;\n* difficulty in identifying the anatomic landmarks;\n* unstable cervical spine fracture;\n* international normalized ratio (INR) \\>2;\n* platelet count \\<50 000 mm3.'}, 'identificationModule': {'nctId': 'NCT03141294', 'briefTitle': 'Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial', 'orgStudyIdInfo': {'id': '2017-SR-078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'sd-PDT group', 'description': 'The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.', 'interventionNames': ['Procedure: reformative dilation technique']}, {'type': 'EXPERIMENTAL', 'label': 're-PDT group', 'description': 'The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.', 'interventionNames': ['Procedure: reformative dilation technique']}], 'interventions': [{'name': 'reformative dilation technique', 'type': 'PROCEDURE', 'otherNames': ['reformative tracheostomy'], 'description': 'reformative dilation technique was used when operating tracheostomy', 'armGroupLabels': ['re-PDT group', 'sd-PDT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affliated Hospital wiht Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Jinhai Li', 'role': 'STUDY_CHAIR', 'affiliation': 'The first Affliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'Jinhai Li', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}