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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05520957
Other study ID # 4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 31, 2022

Study information

Verified date August 2022
Source Cantonal Hospital Zenica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - COVID-19 postive patients - surgery tracheostomy patients Exclusion Criteria: - trachestomy before admission in the ICU

Study Design


Intervention

Procedure:
Tracheostomy
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.

Locations

Country Name City State
Bosnia and Herzegovina Cantonal Hospital Zenica

Sponsors (1)

Lead Sponsor Collaborator
Cantonal Hospital Zenica

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characteristics of tracheotomized COVID-19 patients 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
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