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

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)

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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