Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration (PETRIS)

• ClinicalTrials.gov Identifier: NCT05792098
• Recruitment Status: Enrolling by invitation
• First Posted: March 30, 2023
• Last Update Posted: March 30, 2023
• Sponsor: Charles University, Czech Republic
• Collaborator: Military University Hospital, Prague
• Information provided by (Responsible Party): Charles University, Czech Republic

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Tracheostomy Complication	Procedure: percutaneous dilatational tracheostomy (PDTS); Diagnostic Test: Ultrasound examination; Diagnostic Test: Bronchoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
• Estimated Study Start Date: April 1, 2023
• Estimated Primary Completion Date: April 1, 2025
• Estimated Study Completion Date: December 12, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The guidewire penetration through the thyroid isthmus. [ Time Frame: During procedure ]
   Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy.
2. Monitoring the incidence of early postoperative complications. [ Time Frame: 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 :

1. Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site. [ Time Frame: During procedure ]
   Monitoring the frequency of guidewire position changes based on ultrasound examination.

Other Outcome Measures:

1. Ultrasound-based contraindication rate of percutaneous dilatational tracheostomy. [ Time Frame: During procedure ]
   Monitoring the incidence of tracheostomy technique change from planned percutaneous dilatation to surgical approach based on ultrasound examination.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• not willing to participate

Contacts and Locations

Locations

Czechia

Military University Hospital Prague

Prague, Czechia, 16902

Sponsors and Collaborators

Charles University, Czech Republic

Military University Hospital, Prague

Investigators

• Study Chair: Ilona Trtíková, Mgr., Ph.D.; CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

More Information

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.

• Responsible Party: Charles University, Czech Republic
• ClinicalTrials.gov Identifier: NCT05792098
• Other Study ID Numbers: PETRIS_01
• First Posted: March 30, 2023
• Last Update Posted: March 30, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Charles University, Czech Republic:

percutaneous dilatational tracheostomy; ultrasound; mechanical ventilation