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

Tracheostomy Complication Clinical Trial

— BRONCUS-PDT  

Official title:

The Ultrasound-guided Versus Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Dilational Tracheostomy Trial - Standardization or Customization?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226142
• Other study ID #: UMF-USBR-2024-001
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Universitatea de Medicina si Farmacie Iuliu Hatieganu
• Contact: Catalin Constantinescu, MD, PhD
• Phone: 0040743903224
• Email: constantinescu.catalin[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2026
• Est. primary completion date: January 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hemorrhage
• Tracheostomy Complication
• Tracheostomy Hemorrhage
• Tracheostomy Infection

Intervention

Procedure:
• Percutaneous dilatational tracheostomy
Percutaneous dilatational tracheostomy

Locations

Country	Name	City	State
Romania	Emergency County Clinical Hospital	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Universitatea de Medicina si Farmacie Iuliu Hatieganu

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDT feasibility/failure	Conversion to a surgical tracheostomy in any case, associated use of bronchoscopy in the case of ultrasound-guided PDT, associated use of ultrasound in the case of bronchoscopy-guided PDT, or the occurrence of a major complication.	During PDT - 15-25 minutes
Secondary	Minor complication - hypotension	a drop of MAP<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors	During PDT (an expected average of 15-30 minutes)
Secondary	Procedure difficulty	(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible	During PDT (an expected average of 15-30 minutes)
Secondary	ICU mortality	We will measure ICU mortality at the discharge and 60 days after discharge.	During hospital LOS (an expected average of 4 weeks )
Secondary	Hospital mortality	We will measure hospital mortality at the discharge and 60 days after discharge.	During hospital LOS (an expected average of 4 weeks)
Secondary	Procedure duration	We will measure the procedure duration from the point beginning of the procedure and the end of it.	During PDT (an expected average of 15-30 minutes)
Secondary	Mechanical ventilation	Days of MV before and after PDT	During hospital LOS (an expected average of 4 weeks)
Secondary	Minor complication - hypoxemia	A drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oxymeter during the procedure while the patient is of 100% FiO2	During PDT (an expected average of 15-30 minutes)
Secondary	Minor complication - Accidental decannulation	Accidental decannulation	During hospital LOS (an expected average of 4 weeks)
Secondary	Minor complication - Tracheostomy stoma infection	Tracheostomy stoma infection	During hospital LOS (an expected average of 4 weeks)
Secondary	Minor complication - Localized minor bleeding	Localized minor bleeding	During PDT (an expected average of 15-30 minutes)
Secondary	Minor complication - Localized subcutaneous emphysema	Localized subcutaneous emphysema	During PDT (an expected average of 15-30 minutes)
Secondary	Lenght of ICU stay	Lenght of ICU stay	(an expected average of 4 weeks)
Secondary	Lenght of hospital stay	Lenght of hospital stay	(an expected average of 4 weeks)