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| Name | Class |
|---|---|
| Military University Hospital, Prague | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Ultrasound navigated group | Active Comparator | Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous dilatational tracheostomy (PDTS) | Procedure | Tracheostomy made by percutaneous dilatational technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site. | Monitoring the frequency of guidewire position changes based on ultrasound examination. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound-based contraindication rate of percutaneous dilatational tracheostomy. | Monitoring the incidence of tracheostomy technique change from planned percutaneous dilatation to surgical approach based on ultrasound examination. | During procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilona TrtÃková, Mgr., Ph.D. | CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military University Hospital Prague | Prague | 16902 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26831676 | Background | 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. | |
| 31268274 |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| Ultrasound examination | Diagnostic Test | Ultrasound verification of guidewire position |
|
| Bronchoscopy | Diagnostic Test | Bronchoscopic control of guidewire position |
|
| Background |
| Plata P, Gaszynski T. Ultrasound-guided percutaneous tracheostomy. Anaesthesiol Intensive Ther. 2019;51(2):126-132. doi: 10.5114/ait.2019.86277. |
| 42217576 | Derived | Rara A, Sotak M, Hynek M, Kovacic K, Filipovsky T, Tyll T. Percutaneous dilatational tracheostomy and thyroid isthmus penetration (PETRIS). Anaesth Crit Care Pain Med. 2026 May 30;45(6):101863. doi: 10.1016/j.accpm.2026.101863. Online ahead of print. |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |