Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT05520957
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early SARS-CoV-2 Tracheostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}, {'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_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-08-28', 'studyFirstSubmitQcDate': '2022-08-28', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of tracheotomized COVID-19 patients', 'timeFrame': '2 years', 'description': 'We analysed age, sex, existing comorbidities, duration indicators (length of endotracheal intubation, day of tracheotomy, length of stay in the intensive care unit (ICU), and total length of hospital stay), respirator weaning marked with YES / NO. From the laboratory parameters, we analyzed: lactate, urea, creatinine, potassium and D-dimer. They were collected at two time intervals, before tracheotomy and after tracheotomy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'tracheostomy', 'demographic', 'lactate', 'D-dimer'], 'conditions': ['Tracheostomy', 'Characteristics Disease', 'Metabolic Disturbance']}, 'descriptionModule': {'briefSummary': 'Objective of this case series was to evaluate the characteristics of early COVID-19 tracheostomy and its effect on laboratory parameters. A series of 17 patients with COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant difference (p \\<0.05), with laboratory parameters without statistically difference. Critically ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and D-Dimer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We performed a retrospective review of all COVID-19 critically ill patients who underwent tracheotomy between 2020 and 2022. All tracheotomized patients were included in the analysis, age 18 and older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 postive patients\n* surgery tracheostomy patients\n\nExclusion Criteria:\n\n* trachestomy before admission in the ICU'}, 'identificationModule': {'nctId': 'NCT05520957', 'briefTitle': 'Early SARS-CoV-2 Tracheostomy', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital Zenica'}, 'officialTitle': 'Early Tracheostomy in COVID-19 Critically Ill Patients: A Retrospective Case Series', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tracheostomy', 'type': 'PROCEDURE', 'description': 'We collected data from all tracheotomised patients including age, sex, existing comorbidities, duration indicators (length of endotracheal intubation, day of tracheotomy, length of stay in the intensive care unit (ICU), and total length of hospital stay), respirator weaning marked with YES / NO. From the laboratory parameters, we analyzed: lactate, urea, creatinine, potassium and D-dimer. They were collected at two time intervals, before tracheotomy and after tracheotomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Zenica', 'country': 'Bosnia and Herzegovina', 'facility': 'Cantonal Hospital', 'geoPoint': {'lat': 44.20169, 'lon': 17.90397}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital Zenica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Mirza Kovacevic', 'investigatorAffiliation': 'Cantonal Hospital Zenica'}}}}