TracheostomyNCT04447638
Percutaneous Tracheostomy With COVID-19
An observational study of Tracheostomy, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Tracheostomy with aerosol box in COVID-19 positive patients
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 1 Jun 2020
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Percutaneous tracheostomy performed with aerosol box in COVID-19 patients
Who may be able to join
- who underwent percutaneous tracheostomy with COVID-19(+)
Who cannot join
- Patients who do not give informed consent or do not want to participate in the study
- Coagulopathy, thrombocytopenia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, 17020
About this study
Official title: Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.
Read the detailed description
Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.
- Conditions
- Tracheostomy
- Being tested
- Tracheostomy with aerosol box in COVID-19 positive patients
- Keywords
- Reanimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheostomy with aerosol box in COVID-19 positive patientsProcedure or surgery
Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box
Complications
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 Mar 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut ERBAS, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447638
- Sponsor's protocol ID
- TT17
- Status last verified
- Sep 2020
- First submitted
- 24 Jun 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
- ClinicalTrials.gov ID
- NCT04447638
- Acronym / sponsor ID
- TT17
- Conditions
- Tracheostomy
- Keywords
- Reanimation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 25 Jun 2020 (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.
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.
Detailed description
Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Percutaneous tracheostomy performed with aerosol box in COVID-19 patients
Key inclusion criteria (1 listed)
- who underwent percutaneous tracheostomy with COVID-19(+)
Key exclusion criteria (2 listed)
- Patients who do not give informed consent or do not want to participate in the study
- Coagulopathy, thrombocytopenia
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 |
|---|---|---|
| Tracheostomy with aerosol box in COVID-19 positive patientsPatients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded. | Procedure or surgery | – |
Primary outcome
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box
Time frame: During the procedure
Complications
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 24 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 24 Sep 2020. 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 Turkey (Türkiye). 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?
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box (time frame: During the procedure). 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 24 Sep 2020.