Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-30 @ 2:53 AM
Study NCT ID:
NCT01502657
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2011-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Percutaneous Tracheostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-12-30', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure related complications', 'timeFrame': 'At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks', 'description': 'Complications are: 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 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma.'}], 'secondaryOutcomes': [{'measure': 'Procedure time', 'timeFrame': 'The time will be calculated at the end of the procedure; an average of 30 minutes', 'description': 'The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous tracheostomy', 'ultrasonography', 'echography', 'critical care'], 'conditions': ['Tracheostomy Hemorrhage', 'Tracheostomy Complications', 'Other Tracheostomy Complications']}, 'referencesModule': {'references': [{'pmid': '22390815', 'type': 'RESULT', 'citation': 'Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.', 'detailedDescription': 'Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients hospitalized in ICU in whom percutaneous tracheostomy is indicated,\n* patients aged \\> 18 years old,\n\nExclusion Criteria:\n\n* age less than 18 years,\n* clotting disorder,\n* infection at the puncture site,\n* emergency tracheostomy'}, 'identificationModule': {'nctId': 'NCT01502657', 'briefTitle': 'Ultrasound Guided Percutaneous Tracheostomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Ultrasound Guided Percutaneous Tracheostomy in the ICU', 'orgStudyIdInfo': {'id': 'PI10-DR-GUINOT'}, 'secondaryIdInfos': [{'id': '2010-A00901-38', 'type': 'OTHER', 'domain': 'RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonography (EnVisor Philips Medical Systems)', 'type': 'DEVICE', 'otherNames': ['Echograph is EnVisor Philips', 'N°453561299512 rev A', 'CE0086'], 'description': 'Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'state': 'Somme', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Pierre grégoire Guinot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire, Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}