Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration (PETRIS)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Tracheostomy Complication
• Intervention / Treatment: Procedure: percutaneous dilatational tracheostomy (PDTS); Diagnostic test: Bronchoscopy; Diagnostic test: Ultrasound examination

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 16902
    • Military University Hospital Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• not willing to participate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard procedure group; 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); Tracheostomy made by percutaneous dilatational technique; Diagnostic test: Bronchoscopy; Bronchoscopic control of guidewire position
Active Comparator: Ultrasound navigated group; Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.	Procedure: percutaneous dilatational tracheostomy (PDTS); Tracheostomy made by percutaneous dilatational technique; Diagnostic test: Bronchoscopy; Bronchoscopic control of guidewire position; Diagnostic test: Ultrasound examination; Ultrasound verification of guidewire position

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Military University Hospital, Prague
• Investigators: Study Chair: Ilona Trtíková, Mgr., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): December 12, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: mechanical ventilation; ultrasound; percutaneous dilatational tracheostomy
• Other Study ID Numbers: PETRIS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No