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: April 11, 2023
• Sponsor: Charles University, Czech Republic
• Collaborator: Military University Hospital, Prague
• Information provided by (Responsible Party): Charles University, Czech Republic

Tracking Information

• First Submitted Date: March 7, 2023
• First Posted Date: March 30, 2023
• Last Update Posted Date: April 11, 2023
• Actual Study Start Date: April 6, 2023
• Estimated Primary Completion Date: April 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2023)

• 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.
• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 29, 2023)

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 29, 2023)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
• Official Title: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Tracheostomy Complication

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Procedure: percutaneous dilatational tracheostomy (PDTS)
  • Diagnostic Test: Bronchoscopy
• Active Comparator: Ultrasound navigated group
  Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.
  Interventions:

  • Procedure: percutaneous dilatational tracheostomy (PDTS)
  • Diagnostic Test: Ultrasound examination
  • Diagnostic Test: Bronchoscopy

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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 29, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 12, 2025
• Estimated Primary Completion Date: April 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• not willing to participate

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia

Administrative Information

• NCT Number: NCT05792098
• Other Study ID Numbers: PETRIS_01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Charles University, Czech Republic
• Original Responsible Party: Same as current
• Current Study Sponsor: Charles University, Czech Republic
• Original Study Sponsor: Same as current
• 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

• PRS Account: Charles University, Czech Republic
• Verification Date: March 2023