NCT05792098

Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheostomy Complication

Interventions

Type	Name	Description
PROCEDURE	percutaneous dilatational tracheostomy (PDTS)	Tracheostomy made by percutaneous dilatational technique
DIAGNOSTIC_TEST	Ultrasound examination	Ultrasound verification of guidewire position
DIAGNOSTIC_TEST	Bronchoscopy	Bronchoscopic control of guidewire position

Timeline

• Start date: 2023-04-06
• Primary completion: 2025-04-01
• Completion: 2025-12-12
• First posted: 2023-03-30
• Last updated: 2023-04-11

Locations

1 site across 1 country: Czechia