Clincosm LogoSign in Get a demo

PETRIS: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05792098
Collaborator
Military University Hospital, Prague (Other)
200
Enrollment
1
Location
2
Arms
32.4
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

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

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
Anticipated 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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Dec 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. [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. [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. [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. [During procedure]

    Monitoring the incidence of tracheostomy technique change from planned percutaneous dilatation to surgical approach based on ultrasound examination.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18 Years and older

  • long-term need for mechanical ventilation

Exclusion Criteria:
  • not willing to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT05792098
Other Study ID Numbers:
  • PETRIS_01
First Posted:
Mar 30, 2023
Last Update Posted:
Mar 30, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Mar 30, 2023