Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 1:24 PM
Study NCT ID:
NCT05682651
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Post-Intubation Tracheal Stenosis and Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014135', 'term': 'Tracheal Stenosis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2023-01-07', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Up to 3 months', 'description': 'Duration of intubation of patients (in days)'}, {'measure': 'Morbidity/mortality', 'timeFrame': 'Up to 2 months', 'description': 'Morbidity/mortality status of the patients within 3 months'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 3 months', 'description': 'The hospital stay of the patients will be recorded (in days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheal Stenosis', 'COVID-19', 'Post-Intubation Subglottic Stenosis', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.\n\nIt is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.\n\nThis study will contribute to the measures that can be taken during and after the care process in the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years of age and without a history of malignancy who developed post-intubation tracheal stenosis are included in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n\nExclusion Criteria:\n\n* Patients undergoing surgical procedures for malignancy'}, 'identificationModule': {'nctId': 'NCT05682651', 'briefTitle': 'Relationship Between Post-Intubation Tracheal Stenosis and Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': "Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review", 'orgStudyIdInfo': {'id': 'E.Kurul-E1-22-3142'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tracheal Stenosis with Covid-19', 'description': "Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.", 'interventionNames': ['Procedure: tracheal stenosis follow-up file']}, {'label': 'Tracheal Stenosis with Non-Covid-19', 'description': "Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.", 'interventionNames': ['Procedure: tracheal stenosis follow-up file']}], 'interventions': [{'name': 'tracheal stenosis follow-up file', 'type': 'PROCEDURE', 'description': "Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.", 'armGroupLabels': ['Tracheal Stenosis with Covid-19', 'Tracheal Stenosis with Non-Covid-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06290', 'city': 'Çankaya', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.9179, 'lon': 32.86268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Nilgün Zengin', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}