Clinical trial NCT06226142: The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial
Official title: The Ultrasound-guided Versus Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Dilational Tracheostomy Trial - Standardization or Customization?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheostomy Complication
Tracheostomy Infection
Tracheostomy Hemorrhage
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: PDT feasibility/failure
timeFrame: During PDT - 15-25 minutes
Secondary outcomes:
measure: Minor complication - hypotension
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: Procedure difficulty
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: ICU mortality
timeFrame: During hospital LOS (an expected average of 4 weeks )
measure: Hospital mortality
timeFrame: During hospital LOS (an expected average of 4 weeks)
measure: Procedure duration
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: Mechanical ventilation
timeFrame: During hospital LOS (an expected average of 4 weeks)
measure: Minor complication - hypoxemia
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: Minor complication - Accidental decannulation
timeFrame: During hospital LOS (an expected average of 4 weeks)
measure: Minor complication - Tracheostomy stoma infection
timeFrame: During hospital LOS (an expected average of 4 weeks)
measure: Minor complication - Localized minor bleeding
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: Minor complication - Localized subcutaneous emphysema
timeFrame: During PDT (an expected average of 15-30 minutes)
measure: Lenght of ICU stay
timeFrame: (an expected average of 4 weeks)
measure: Lenght of hospital stay
timeFrame: (an expected average of 4 weeks)
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Emergency County Clinical Hospital
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Cristina Petrisor, Prof
role: STUDY_CHAIR
References: