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

NCT ID: NCT05845775

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-02-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Tracheostomy Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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percutaneous dilatational tracheostomy

Patients assigned to percutaneous dilatational tracheostomy

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy

Bronchoscopy

Intervention Type DEVICE

Fiberoptic bronchoscopy

ultrasonography

Intervention Type DEVICE

ultrasonography

Bronchoscopy application

Intervention Type DIAGNOSTIC_TEST

Fiberoptic bronchoscopy application

Ultrasound examination

Intervention Type DIAGNOSTIC_TEST

Ultrasound examination

Interventions

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Percutaneous dilatational tracheostomy

The percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy

Intervention Type PROCEDURE

Bronchoscopy

Fiberoptic bronchoscopy

Intervention Type DEVICE

ultrasonography

ultrasonography

Intervention Type DEVICE

Bronchoscopy application

Fiberoptic bronchoscopy application

Intervention Type DIAGNOSTIC_TEST

Ultrasound examination

Ultrasound examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melike Cengiz

OTHER

Sponsor Role lead

Responsible Party

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Melike Cengiz

MD, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Esin Bulut, MD

Role: STUDY_DIRECTOR

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

Locations

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

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Akdeniz University Medicine

Identifier Type: -

Identifier Source: org_study_id

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