TracheostomyNCT05520957
Early SARS-CoV-2 Tracheostomy
An observational study of Tracheostomy and Characteristics Disease, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheostomy, Characteristics Disease, Metabolic Disturbance
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2020to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- COVID-19 postive patients
- surgery tracheostomy patients
Who cannot join
- trachestomy before admission in the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tracheostomy, Characteristics Disease, Metabolic Disturbance
- Being tested
- Tracheostomy
- Keywords
- COVID-19, tracheostomy, demographic, lactate, D-dimer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jan 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital Zenica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirza Kovacevic, Cantonal Hospital Zenica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520957
- Sponsor's protocol ID
- 4
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Tracheostomy in COVID-19 Critically Ill Patients: A Retrospective Case Series
- ClinicalTrials.gov ID
- NCT05520957
- Acronym / sponsor ID
- 4
- Conditions
- Tracheostomy, Characteristics Disease, Metabolic Disturbance
- Keywords
- COVID-19, tracheostomy, demographic, lactate, D-dimer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cantonal Hospital ZenicaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COVID-19 postive patients
- surgery tracheostomy patients
Key exclusion criteria (1 listed)
- trachestomy before admission in the ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TracheostomyWe 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. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy and Characteristics Disease, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of tracheotomized COVID-19 patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.