Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04637932
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complication of percutan dilatation tracheostomy procedure.', 'timeFrame': '7 days', 'description': 'blood gas analysis, physical examination, lung auscultation, hemodynamics parameters'}], 'secondaryOutcomes': [{'measure': 'processing time.', 'timeFrame': 'minutes', 'description': 'Our secondary goal is to compare in terms of processing time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['percutan tracheostomy', 'bronchoscopy', 'pro-seal Laryngeal mask'], 'conditions': ['Tracheostomy Complication']}, 'descriptionModule': {'briefSummary': 'In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.', 'detailedDescription': 'Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.\n\nElective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.\n\nIn the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.\n\nIn the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.\n\nArterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.\n\nThe time until the end of the procedure and complications were determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study.\n\n\\-\n\nExclusion Criteria:\n\n* history of cervical trauma,\n* high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),\n* pulmonary edema,\n* acute respiratory distress'}, 'identificationModule': {'nctId': 'NCT04637932', 'briefTitle': 'Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy', 'orgStudyIdInfo': {'id': '2020/60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Use of endotracheal tube During Percutaneous Dilatation Tracheostomy', 'description': 'Group 1 was determined as endotracheal tube', 'interventionNames': ['Procedure: Percutaneous Dilatation Tracheostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy', 'description': 'group 2 as pro-seal laryngeal mask group.', 'interventionNames': ['Procedure: Percutaneous Dilatation Tracheostomy']}], 'interventions': [{'name': 'Percutaneous Dilatation Tracheostomy', 'type': 'PROCEDURE', 'otherNames': ['Bronchoscopy'], 'description': 'pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.', 'armGroupLabels': ['Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy', 'Use of endotracheal tube During Percutaneous Dilatation Tracheostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sitki Kocman University', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'semra Demirbilek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eylem Yaşar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Muğla Sıtkı Koçman Universty', 'investigatorFullName': 'Eylem Yaşar', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}