The Ultrasound-guided Versus Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Dilational Tracheostomy Trial - Standardization or Customization?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheostomy Complication
- Sponsor
- Universitatea de Medicina si Farmacie Iuliu Hatieganu
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- PDT feasibility/failure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Constantinescu Catalin
Assistant lecturer, PhD
Universitatea de Medicina si Farmacie Iuliu Hatieganu
Eligibility Criteria
Inclusion Criteria
- •adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
PDT feasibility/failure
Time Frame: 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 Outcomes
- ICU mortality(During hospital LOS (an expected average of 4 weeks ))
- Hospital mortality(During hospital LOS (an expected average of 4 weeks))
- Minor complication - hypotension(During PDT (an expected average of 15-30 minutes))
- Lenght of ICU stay((an expected average of 4 weeks))
- Procedure duration(During PDT (an expected average of 15-30 minutes))
- Minor complication - Localized minor bleeding(During PDT (an expected average of 15-30 minutes))
- Procedure difficulty(During PDT (an expected average of 15-30 minutes))
- Mechanical ventilation(During hospital LOS (an expected average of 4 weeks))
- Lenght of hospital stay((an expected average of 4 weeks))
- Minor complication - hypoxemia(During PDT (an expected average of 15-30 minutes))
- Minor complication - Tracheostomy stoma infection(During hospital LOS (an expected average of 4 weeks))
- Minor complication - Accidental decannulation(During hospital LOS (an expected average of 4 weeks))
- Minor complication - Localized subcutaneous emphysema(During PDT (an expected average of 15-30 minutes))