Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT01792258
Status:
UNKNOWN
Last Update Posted:
2016-02-03
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of percutaneous tracheostomy', 'timeFrame': 'at the beginning and at the end of the procedure'}], 'secondaryOutcomes': [{'measure': 'Early complications', 'timeFrame': 'in the first 24 hours from the end of the procedure', 'description': 'Early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax'}, {'measure': 'Late complications', 'timeFrame': 'from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)', 'description': 'Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.'}, {'measure': 'Quality of life', 'timeFrame': 'at 3, 6 and 12 months after tracheostomy', 'description': 'The investigator will use the EURO-QOL'}, {'measure': 'Evaluation of organ function', 'timeFrame': 'At 3, 6 , and 12 months after tracheostomy', 'description': 'The investigator will perform a flexible fiberoptic laryngoscopy.'}, {'measure': 'Quality of voice', 'timeFrame': 'At 3,6, 12 months after tracheostomy', 'description': 'the investigator will use a KAY elemetrics analyzer.'}, {'measure': 'Mortality', 'timeFrame': 'at 3, 6 and 12 months from tracheostomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous tracheostomy', 'Intensive Care Unit', 'Ineffective Airway Clearance', 'Weaning failure'], 'conditions': ['Acute Respiratory Failure', 'Neurological Disease', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Criticall ill patients requiring percutaneous tracheostomy in intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18\n* indication for tracheostomy\n\nExclusion Criteria:\n\n* infectious disease of neck'}, 'identificationModule': {'nctId': 'NCT01792258', 'briefTitle': 'Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': 'Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit', 'orgStudyIdInfo': {'id': '53/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critical ill patients', 'description': 'The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU', 'interventionNames': ['Procedure: Percutaneous tracheostomy']}], 'interventions': [{'name': 'Percutaneous tracheostomy', 'type': 'PROCEDURE', 'description': 'Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.', 'armGroupLabels': ['critical ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genoa', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Pelosi, professor', 'role': 'CONTACT', 'email': 'ppelosi@hotmail.com', 'phone': '+39 010 555 3136'}, {'name': 'Paolo Pelosi, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria Vargas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iole Brunetti, md', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Genoa', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}], 'centralContacts': [{'name': 'Paolo Pelosi, professor', 'role': 'CONTACT', 'email': 'ppelosi@hotmail.com', 'phone': '+39 010 5553136'}], 'overallOfficials': [{'name': 'Paolo Pelosi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita degli Studi di Genova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paolo Pelosi', 'investigatorAffiliation': 'University of Genova'}}}}