- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520957
Early SARS-CoV-2 Tracheostomy
August 30, 2022 updated by: Mirza Kovacevic, Cantonal Hospital Zenica
Early Tracheostomy in COVID-19 Critically Ill Patients: A Retrospective Case Series
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zenica, Bosnia and Herzegovina, 72000
- Cantonal Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- COVID-19 postive patients
- surgery tracheostomy patients
Exclusion Criteria:
- trachestomy before admission in the ICU
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characteristics of tracheotomized COVID-19 patients
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2020
Primary Completion (ACTUAL)
January 31, 2022
Study Completion (ACTUAL)
January 31, 2022
Study Registration Dates
First Submitted
August 28, 2022
First Submitted That Met QC Criteria
August 28, 2022
First Posted (ACTUAL)
August 30, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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