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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Tracheostomy Complication, Tracheostomy Infection, Tracheostomy Hemorrhage

NCT06226142

Universitatea de Medicina si Farmacie Iuliu Hatieganu

29 January 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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