Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Study Overview
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Brief Summary
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A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).

Detailed Description
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A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. Patients indicated by the attending physician to percutaneous dilatational tracheostomy (PDTS) due to long-term need for mechanical ventilation will be randomly divided into two groups. The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. In the second group, the attending physician will additionally use ultrasound navigation during the procedure. After insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. In case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the PDTS completed.

Official Title
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Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Procedure: percutaneous dilatational tracheostomy (PDTS)
* Diagnostic Test: Ultrasound examination
* Diagnostic Test: Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years and older long-term need for mechanical ventilation Exclusion Criteria: not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard procedure group<br>The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic control. | Procedure: percutaneous dilatational tracheostomy (PDTS)<br>* Tracheostomy made by percutaneous dilatational technique<br>Diagnostic Test: Bronchoscopy<br>* Bronchoscopic control of guidewire position<br>|
| Active Comparator: Ultrasound navigated group<br>Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure. | Procedure: percutaneous dilatational tracheostomy (PDTS)<br>* Tracheostomy made by percutaneous dilatational technique<br>Diagnostic Test: Ultrasound examination<br>* Ultrasound verification of guidewire position<br>Diagnostic Test: Bronchoscopy<br>* Bronchoscopic control of guidewire position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The guidewire penetration through the thyroid isthmus. | Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy. | During procedure | 
| Monitoring the incidence of early postoperative complications. | The incidence of bleeding from tracheostomy canal during hospitalization depending on guidewire position, defined as the need for any intervention to stop the bleeding. The incidence of tracheostomy canal infection during hospitalization depending on guidewire position, defined as the presence of any clinical signs of inflammation (swelling, redness, pain, secretion production, dehiscence). | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site. | Monitoring the frequency of guidewire position changes based on ultrasound examination. | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous dilatational tracheostomy, ultrasound, mechanical ventilation