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Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration (PETRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05792098
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2023
Last Update Posted : April 11, 2023
Sponsor:
Collaborator:
Military University Hospital, Prague
Information provided by (Responsible Party):
Charles University, Czech Republic

Study Description
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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
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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
Actual Study Start Date : April 6, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : December 12, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05792098


Locations
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Czechia
Military University Hospital Prague
Prague, Czechia, 16902
Sponsors and Collaborators
Charles University, Czech Republic
Military University Hospital, Prague
Investigators
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Study Chair: Ilona Trtíková, Mgr., Ph.D. CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
More Information
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Publications:

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Responsible Party: Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT05792098    
Other Study ID Numbers: PETRIS_01
First Posted: March 30, 2023    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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