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

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy Complication
• Intervention / Treatment: Procedure: Percutaneous dilatational tracheostomy; Device: Bronchoscopy; Device: ultrasonography; Diagnostic test: Bronchoscopy application; Diagnostic test: Ultrasound examination

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 Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
percutaneous dilatational tracheostomy; Patients assigned to percutaneous dilatational tracheostomy	Procedure: Percutaneous dilatational tracheostomy; The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy; Device: Bronchoscopy; Fiberoptic bronchoscopy; Device: ultrasonography; ultrasonography; Diagnostic test: Bronchoscopy application; Fiberoptic bronchoscopy application; Diagnostic test: Ultrasound examination; Ultrasound examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Melike Cengiz
• Investigators: Study Director: Esin Bulut, MD, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Complications; Tracheostomy
• Other Study ID Numbers: Akdeniz University Medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No