Clinical trial NCT05792098: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
Official title: Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tracheostomy Complication
Keywords: percutaneous dilatational tracheostomy
ultrasound
mechanical ventilation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2023-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not willing to participate

Primary outcomes:
measure: The guidewire penetration through the thyroid isthmus.
timeFrame: During procedure
measure: Monitoring the incidence of early postoperative complications.
timeFrame: Up to 10 days
Secondary outcomes:
measure: Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.
timeFrame: During procedure
Other outcomes:
measure: Ultrasound-based contraindication rate of percutaneous dilatational tracheostomy.
timeFrame: During procedure
Locations:
city: Prague
country: Czechia
facility: Military University Hospital Prague
Study officials:
affiliation: CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
name: Ilona Trtíková, Mgr., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: Plata P, Gaszynski T. Ultrasound-guided percutaneous tracheostomy. Anaesthesiol Intensive Ther. 2019;51(2):126-132. doi: 10.5114/ait.2019.86277.