CClinicalTrials.gg
CompletedNCT05845775Updated Mar 19, 2024

Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications

An observational study in Tracheostomy Complication, sponsored by Melike Cengiz. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Melike Cengiz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tracheostomy Complication

Keywords

  • Complications
  • Intensive care unit
  • Tracheostomy
03

In context

Lead sponsor

Melike Cengiz is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Example:

● Patients undergoing percutaneous dilatational tracheotomy

Inclusion criteria

Inclusion Criteria:

● Clinical indication for tracheostomy

Exclusion criteria

Exclusion Criteria:

  • Age \<18
  • Patients with severe coagulopathy
  • Unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (actual)
Patient registry
No

Groups and cohorts

  • percutaneous dilatational tracheostomy

    Patients assigned to percutaneous dilatational tracheostomy

    Procedure: Percutaneous dilatational tracheostomy · Device: Bronchoscopy · Device: ultrasonography · Diagnostic Test: Bronchoscopy application · Diagnostic Test: Ultrasound examination

Interventions

  • ProcedurePercutaneous dilatational tracheostomy

    The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy

  • DeviceBronchoscopy

    Fiberoptic bronchoscopy

  • Deviceultrasonography

    ultrasonography

  • Diagnostic testBronchoscopy application

    Fiberoptic bronchoscopy application

  • Diagnostic testUltrasound examination

    Ultrasound examination

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: April 30, 2023-October 30, 2023 (6 months)

07

Study locations

1 site
  • Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
    Antalya, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05845775
Lead sponsor
Melike Cengiz
Responsible party
Melike Cengiz (MD, Clinical Professor, Akdeniz University) — Sponsor-investigator
First posted
May 6, 2023
Start date
Apr 30, 2023
Primary completion
Feb 2, 2024
Completion
Feb 2, 2024
Last update
Mar 19, 2024

Study contacts

Esin Bulut, MD
study director · Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion