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

Tracheostomy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05845775
• Other study ID #: Akdeniz University Medicine
• Status: Completed
• Start date: April 30, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: March 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tracheostomy Complication

Intervention

Procedure:
• Percutaneous dilatational tracheostomy
The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy

Device:
• Bronchoscopy
Fiberoptic bronchoscopy
• ultrasonography
ultrasonography

Diagnostic Test:
• Bronchoscopy application
Fiberoptic bronchoscopy application
• Ultrasound examination
Ultrasound examination

Locations

Country	Name	City	State
Turkey	Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Melike Cengiz

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	April 30, 2023-October 30, 2023 (6 months)