Tracheostomy Complication
Conditions
Keywords
percutaneous dilatational tracheostomy, ultrasound, mechanical ventilation
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.
Interventions
PROCEDUREpercutaneous dilatational tracheostomy (PDTS)
Tracheostomy made by percutaneous dilatational technique
DIAGNOSTIC_TESTUltrasound examination
Ultrasound verification of guidewire position
DIAGNOSTIC_TESTBronchoscopy
Bronchoscopic control of guidewire position
Sponsors
Military University Hospital, Prague
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 Years and older * long-term need for mechanical ventilation
Exclusion criteria
* not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Outcome results
None listed