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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05845775
Other study ID # Akdeniz University Medicine
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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