The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial, The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial (BRONCUS-PDT) test The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial (BRONCUS-PDT) (BRONCUS-PDT)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    150
  • sponsor
    Universitatea de Medicina si Farmacie Iuliu Hatieganu
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Updated on 13 June 2024
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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.

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.

Details
Condition Tracheostomy Complication, Tracheostomy Infection, Tracheostomy Hemorrhage
Age 18years or above
Treatment Percutaneous dilatational tracheostomy
Clinical Study IdentifierNCT06226142
SponsorUniversitatea de Medicina si Farmacie Iuliu Hatieganu
Last Modified on13 June 2024

Eligibility

 Yes No Not Sure

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
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