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NCT Number: NCT05845775

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

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.

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Key information

Conditions

Tracheostomy Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Example:

● Patients undergoing percutaneous dilatational tracheotomy

Inclusion criteria

● Clinical indication for tracheostomy

Exclusion criteria

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

Treatment and study plan

Percutaneous dilatational tracheostomy

Procedure

The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy

Bronchoscopy

Device

Fiberoptic bronchoscopy

Ultrasonography

Device

ultrasonography

Bronchoscopy application

Diagnostic Test

Fiberoptic bronchoscopy application

Ultrasound examination

Diagnostic Test

Ultrasound examination

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Melike Cengiz

Other

Registry information

Official study title

Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications By Ultrasonography And Fiberoptic Bronchoscopy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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