Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-01 @ 12:13 AM
Study NCT ID:
NCT01693705
Status:
UNKNOWN
Last Update Posted:
2012-09-26
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014139', 'term': 'Tracheostomy'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-24', 'studyFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with tracheostomy due to respiratory failure who died', 'timeFrame': 'Six months', 'description': 'Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tracheostomy'], 'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'To determine the morbidity and mortality of patients who have undergone percutaneous tracheostomy due to respiratory failure in the critical care unit and after intensive care in the internal medicine department, including follow-up of quality of life of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with respiratory failure who were mechanically ventilated in the critical care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanically ventilated critical care patients\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT01693705', 'briefTitle': 'Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0053-12-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tracheostomy Patients', 'description': 'Critical care patients with respiratory failure who were mechanically ventilated and who underwent tracheostomy', 'interventionNames': ['Procedure: Tracheostomy']}, {'label': 'Non-Tracheostomy Patients', 'description': 'Critical care patients with respiratory failure who were mechanically ventilated but did not undergo tracheostomy'}], 'interventions': [{'name': 'Tracheostomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Tracheostomy Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Boris Isakovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Boris Isakovich, MD', 'role': 'CONTACT', 'email': 'borisi@hy.health.gov.il', 'phone': '972-4-6304460'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}