Tracheostomy ComplicationNCT05845775
Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications
An observational study of Tracheostomy Complication, run by Melike Cengiz at 1 site in Turkey (Türkiye).
Trial summary
In recent years, percutaneous dilatational tracheostomy has become a frequently performed procedure in intensive care units. However, tracheostomy procedure has risks of complications of varying severity, such as bleeding, subcutaneous emphysema, posterior tracheal wall damage, tracheal stenosis, infection, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- Percutaneous dilatational tracheostomy, Bronchoscopy and ultrasonography
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2023to 2 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who were decided to open percutaneous dilatational tracheostomy for various reasons will be included in the study.
Who may be able to join
- ● Clinical indication for tracheostomy
Who cannot join
- Age <18
- Patients with severe coagulopathy
- Unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Antalya
About this study
Official title: Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications By Ultrasonography And Fiberoptic Bronchoscopy
In recent years, percutaneous dilatational tracheostomy has become a frequently performed procedure in intensive care units. However, tracheostomy procedure has risks of complications of varying severity, such as bleeding, subcutaneous emphysema, posterior tracheal wall damage, tracheal stenosis, infection, and fistula in the early and late periods. It is important to determine the anatomical position for tracheal puncture in reducing the risk of complications. It is not always possible to determine the optimal anatomical position for tracheal puncture in patients in the intensive care unit due to reasons such as obesity patient positioning difficulties and tracheal deviation. In this stuy, we have purpose to evaluate the effect of the morphological structure of patients on the dilatational tracheostomy interference location and complications in the percutaneous dilatational tracheostomy procedure (using anatomical landmarks) performed with the forceps dilatation technique, using fiberoptic bronchoscopy and ultrasonography.
Read the detailed description
A prospective observational study will be conducted in the Akdeniz University Hospital at the department of Anesthesiology and Intensive Care. Tracheostomy incision site will be determined by using anatomical landmark in all patients. Before the procedure, detailed anatomical measurements showing the morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage) will be recorded. In addition, measurements will be made and recorded by ultrasonography. In all patients, the percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy and the tracheal puncture level will be confirmed. Tracheostomy related complications will also be recorded.
- Conditions
- Tracheostomy Complication
- Being tested
- Percutaneous dilatational tracheostomy, Bronchoscopy, ultrasonography, Bronchoscopy application, Ultrasound examination
- Keywords
- Complications, Intensive care unit, Tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous dilatational tracheostomyProcedure or surgery
The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy
BronchoscopyDevice
Fiberoptic bronchoscopy
ultrasonographyDevice
ultrasonography
Bronchoscopy applicationDiagnostic test
Fiberoptic bronchoscopy application
Ultrasound examinationDiagnostic test
Ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| percutaneous dilatational tracheostomy | Patients assigned to percutaneous dilatational tracheostomy Receives: Procedure: Percutaneous dilatational tracheostomy; Device: Bronchoscopy; Device: ultrasonography; Diagnostic Test: Bronchoscopy application; Diagnostic Test: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of morphological structure on the percutaneous dilatational tracheostomy
The relationship of anatomical position for tracheal puncture and complications with morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage)
Measured: April 30, 2023-October 30, 2023 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start30 Apr 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Cengiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Cengiz, Akdeniz University
- Investigators
- Esin Bulut, MD, Study director, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845775
- Sponsor's protocol ID
- Akdeniz University Medicine
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2023
- Last updated
- 19 Mar 2024
- Results posted
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications By Ultrasonography And Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT05845775
- Acronym / sponsor ID
- Akdeniz University Medicine
- Conditions
- Tracheostomy Complication
- Keywords
- Complications, Intensive care unit, Tracheostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Melike CengizUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 6 May 2023 (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.
In recent years, percutaneous dilatational tracheostomy has become a frequently performed procedure in intensive care units. However, tracheostomy procedure has risks of complications of varying severity, such as bleeding, subcutaneous emphysema, posterior tracheal wall damage, tracheal stenosis, infection, and fistula in the early and late periods. It is important to determine the anatomical position for tracheal puncture in reducing the risk of complications. It is not always possible to determine the optimal anatomical position for tracheal puncture in patients in the intensive care unit due to reasons such as obesity patient positioning difficulties and tracheal deviation. In this stuy, we have purpose to evaluate the effect of the morphological structure of patients on the dilatational tracheostomy interference location and complications in the percutaneous dilatational tracheostomy procedure (using anatomical landmarks) performed with the forceps dilatation technique, using fiberoptic bronchoscopy and ultrasonography.
Detailed description
A prospective observational study will be conducted in the Akdeniz University Hospital at the department of Anesthesiology and Intensive Care. Tracheostomy incision site will be determined by using anatomical landmark in all patients. Before the procedure, detailed anatomical measurements showing the morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage) will be recorded. In addition, measurements will be made and recorded by ultrasonography. In all patients, the percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy and the tracheal puncture level will be confirmed. Tracheostomy related complications will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous dilatational tracheostomy | – | Procedure: Percutaneous dilatational tracheostomy, Device: Bronchoscopy, Device: ultrasonography, Diagnostic Test: Bronchoscopy application, Diagnostic Test: Ultrasound examinationPatients assigned to percutaneous dilatational tracheostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who were decided to open percutaneous dilatational tracheostomy for various reasons will be included in the study.
Key inclusion criteria (1 listed)
- ● Clinical indication for tracheostomy
Key exclusion criteria (3 listed)
- Age <18
- Patients with severe coagulopathy
- Unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors)
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 |
|---|---|---|
| Percutaneous dilatational tracheostomyThe percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy | Procedure or surgery | percutaneous dilatational tracheostomy |
| BronchoscopyFiberoptic bronchoscopy | Device | percutaneous dilatational tracheostomy |
| ultrasonographyultrasonography | Device | percutaneous dilatational tracheostomy |
| Bronchoscopy applicationFiberoptic bronchoscopy application | Diagnostic test | percutaneous dilatational tracheostomy |
| Ultrasound examinationUltrasound examination | Diagnostic test | percutaneous dilatational tracheostomy |
Primary outcome
The effect of morphological structure on the percutaneous dilatational tracheostomy
Time frame: April 30, 2023-October 30, 2023 (6 months)
The relationship of anatomical position for tracheal puncture and complications with morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage)
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 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Tracheostomy Complication
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Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
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Surveillance, Endoscopy
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.
Esin Bulut, MD study director
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
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 Complication, run by Melike Cengiz 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 3 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 19 Mar 2024. 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?
The effect of morphological structure on the percutaneous dilatational tracheostomy (time frame: April 30, 2023-October 30, 2023 (6 months)). 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 19 Mar 2024.