The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial

Last updated: January 17, 2024
Sponsor: Universitatea de Medicina si Farmacie Iuliu Hatieganu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

Percutaneous dilatational tracheostomy

Clinical Study ID

NCT06226142
UMF-USBR-2024-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients (over 18 years old), intubated, mechanically ventilated, and with anindication for a tracheostomy

Exclusion

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Percutaneous dilatational tracheostomy
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Emergency County Clinical Hospital

    Cluj-Napoca, Cluj 400006
    Romania

    Active - Recruiting

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