Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheostomy Complication
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The guidewire penetration through the thyroid isthmus.
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 Years and older
- •long-term need for mechanical ventilation
Exclusion Criteria
- •not willing to participate
Outcomes
Primary Outcomes
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.
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 Outcomes
- Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.(During procedure)