The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial
- Conditions
- Tracheostomy ComplicationTracheostomy InfectionTracheostomy Hemorrhage
- Interventions
- Procedure: Percutaneous dilatational tracheostomy
- Registration Number
- NCT06226142
- Brief Summary
This trial (BRONCUS) is a randomized one designed to evaluate the overall safety of ultrasound guided compared to bronchoscopy guided compared to ultrasound-bronchoscopy guided percutaneous tracheostomy, in order to find out if universal standardization is required or customized approach can be sufficient.
- Detailed Description
Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy arms, and then the procedure related complications and clinical outcomes will be evaluated and compared between the groups. The procedures will be performed according to standardized practices following hospital guidelines.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
Patients with contraindications for PDT:
- short neck
- tracheal deviation
- difficult anatomy
- previous neck surgery
- cervical trauma or inability to perform neck extension
- preference for surgical tracheostomy by the patient assistant team
- patients unable to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound-bronchoscopy guided percutaneous tracheostomy Percutaneous dilatational tracheostomy The PDT will be performed by the attending physician with the aid of the ultrasound and bronchoscope. Bronchoscopy guided percutaneous tracheostomy Percutaneous dilatational tracheostomy The PDT will be performed by the attending physician exclusively with the aid of the bronchoscope. Ultrasound guided percutaneous tracheostomy Percutaneous dilatational tracheostomy The PDT will be performed by the attending physician exclusively with the aid of the ultrasound.
- Primary Outcome Measures
Name Time Method PDT feasibility/failure During PDT - 15-25 minutes Conversion to a surgical tracheostomy in any case, associated use of bronchoscopy in the case of ultrasound-guided PDT, associated use of ultrasound in the case of bronchoscopy-guided PDT, or the occurrence of a major complication.
- Secondary Outcome Measures
Name Time Method ICU mortality During hospital LOS (an expected average of 4 weeks ) We will measure ICU mortality at the discharge and 60 days after discharge.
Hospital mortality During hospital LOS (an expected average of 4 weeks) We will measure hospital mortality at the discharge and 60 days after discharge.
Minor complication - hypotension During PDT (an expected average of 15-30 minutes) a drop of MAP\<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors
Lenght of ICU stay (an expected average of 4 weeks) Lenght of ICU stay
Procedure duration During PDT (an expected average of 15-30 minutes) We will measure the procedure duration from the point beginning of the procedure and the end of it.
Minor complication - Localized minor bleeding During PDT (an expected average of 15-30 minutes) Localized minor bleeding
Procedure difficulty During PDT (an expected average of 15-30 minutes) (1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible
Mechanical ventilation During hospital LOS (an expected average of 4 weeks) Days of MV before and after PDT
Lenght of hospital stay (an expected average of 4 weeks) Lenght of hospital stay
Minor complication - hypoxemia During PDT (an expected average of 15-30 minutes) A drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oxymeter during the procedure while the patient is of 100% FiO2
Minor complication - Tracheostomy stoma infection During hospital LOS (an expected average of 4 weeks) Tracheostomy stoma infection
Minor complication - Accidental decannulation During hospital LOS (an expected average of 4 weeks) Accidental decannulation
Minor complication - Localized subcutaneous emphysema During PDT (an expected average of 15-30 minutes) Localized subcutaneous emphysema
Trial Locations
- Locations (1)
Emergency County Clinical Hospital
🇷🇴Cluj-Napoca, Cluj, Romania