Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Tracheostomy Complication Clinical Trial

— PETRIS  

Official title:

Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05792098
• Other study ID #: PETRIS_01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: December 12, 2025

Study information

• Verified date: March 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 12, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 Years and older

• long-term need for mechanical ventilation

Exclusion Criteria:

• not willing to participate

Related Conditions & MeSH terms

• Tracheostomy Complication

Intervention

Procedure:
• percutaneous dilatational tracheostomy (PDTS)
Tracheostomy made by percutaneous dilatational technique

Diagnostic Test:
• Ultrasound examination
Ultrasound verification of guidewire position
• Bronchoscopy
Bronchoscopic control of guidewire position

Locations

Country	Name	City	State
Czechia	Military University Hospital Prague	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Gobatto ALN, Besen BAMP, Tierno PFGMM, Mendes PV, Cadamuro F, Joelsons D, Melro L, Carmona MJC, Santori G, Pelosi P, Park M, Malbouisson LMS. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial. Intensive Care Med. 2016 Mar;42(3):342-351. doi: 10.1007/s00134-016-4218-6. Epub 2016 Feb 1. — View Citation

Plata P, Gaszynski T. Ultrasound-guided percutaneous tracheostomy. Anaesthesiol Intensive Ther. 2019;51(2):126-132. doi: 10.5114/ait.2019.86277. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasound-based contraindication rate of percutaneous dilatational tracheostomy.	Monitoring the incidence of tracheostomy technique change from planned percutaneous dilatation to surgical approach based on ultrasound examination.	During procedure
Primary	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
Primary	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	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