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

U

Universitatea de Medicina si Farmacie Iuliu Hatieganu

Status

Enrolling

Conditions

Tracheostomy Hemorrhage
Tracheostomy Complication
Tracheostomy Infection

Treatments

Procedure: Percutaneous dilatational tracheostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06226142
UMF-USBR-2024-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

Ultrasound guided percutaneous tracheostomy
Experimental group
Description:
The PDT will be performed by the attending physician exclusively with the aid of the ultrasound.
Treatment:
Procedure: Percutaneous dilatational tracheostomy
Bronchoscopy guided percutaneous tracheostomy
Active Comparator group
Description:
The PDT will be performed by the attending physician exclusively with the aid of the bronchoscope.
Treatment:
Procedure: Percutaneous dilatational tracheostomy
Ultrasound-bronchoscopy guided percutaneous tracheostomy
Active Comparator group
Description:
The PDT will be performed by the attending physician with the aid of the ultrasound and bronchoscope.
Treatment:
Procedure: Percutaneous dilatational tracheostomy

Trial contacts and locations

1

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Central trial contact

Catalin Constantinescu, MD, PhD; Olga Grajdieru, MD

Data sourced from clinicaltrials.gov

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