Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Not Applicable

• Conditions: Tracheostomy Complication
• Interventions: Procedure: percutaneous dilatational tracheostomy (PDTS); Diagnostic Test: Ultrasound examination; Diagnostic Test: Bronchoscopy

• Registration Number: NCT05792098
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-30
• Study Start: 2023-04-06
• Last Update Submitted: 2023-04-08
• Last Update Posted: 2023-04-11
• Primary Completion: 2025-04-01
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 Years and older
• long-term need for mechanical ventilation

Exclusion Criteria

• not willing to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound navigated group	percutaneous dilatational tracheostomy (PDTS)	Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.
Ultrasound navigated group	Ultrasound examination	Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.
Standard procedure group	percutaneous dilatational tracheostomy (PDTS)	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.
Standard procedure group	Bronchoscopy	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.
Ultrasound navigated group	Bronchoscopy	Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.

Primary Outcome Measures

Name	Time	Method
The guidewire penetration through the thyroid isthmus.	During procedure	Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy.
Monitoring the incidence of early postoperative complications.	Up to 10 days	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).

Secondary Outcome Measures

Name	Time	Method
Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.	During procedure	Monitoring the frequency of guidewire position changes based on ultrasound examination.

Trial Locations

Locations (1)

Military University Hospital Prague; 🇨🇿 Prague, Czechia