Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

104

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

April 15, 2023

Completed

15 days until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed

Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

April 15, 2023

Last Update Submit

March 17, 2024

Conditions

Tracheostomy Complication

Keywords

ComplicationsIntensive care unitTracheostomy

Outcome Measures

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)
April 30, 2023-October 30, 2023 (6 months)

Study Arms (1)

percutaneous dilatational tracheostomy

Patients assigned to percutaneous dilatational tracheostomy

Procedure: Percutaneous dilatational tracheostomyDevice: BronchoscopyDevice: ultrasonographyDiagnostic Test: Bronchoscopy applicationDiagnostic Test: Ultrasound examination