NCT05792098

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 7, 2023

Last Update Submit

April 8, 2023

Conditions

Tracheostomy Complication

Keywords

percutaneous dilatational tracheostomyultrasoundmechanical ventilation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.

    During procedure

Other Outcomes (1)

  • Ultrasound-based contraindication rate of percutaneous dilatational tracheostomy.

    During procedure

Study Arms (2)

Standard procedure group

ACTIVE COMPARATOR

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)Diagnostic Test: Bronchoscopy

Ultrasound navigated group

ACTIVE COMPARATOR

Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.

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

Interventions

percutaneous dilatational tracheostomy (PDTS)PROCEDURE

Tracheostomy made by percutaneous dilatational technique

Standard procedure groupUltrasound navigated group
Ultrasound examinationDIAGNOSTIC_TEST

Ultrasound verification of guidewire position

Ultrasound navigated group
BronchoscopyDIAGNOSTIC_TEST

Bronchoscopic control of guidewire position

Standard procedure groupUltrasound navigated group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military University Hospital Prague

Prague, 16902, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 26831676BACKGROUND

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

    PMID: 31268274BACKGROUND

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Ilona Trtíková, Mgr., Ph.D.

    CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 30, 2023

Study Start

April 6, 2023

Primary Completion

April 1, 2025

Study Completion

December 12, 2025

Last Updated

April 11, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)