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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy Complication; Tracheostomy Infection; Tracheostomy Hemorrhage
• Intervention / Treatment: Procedure: Percutaneous dilatational tracheostomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catalin Constantinescu, MD, PhD; Phone Number: 0040743903224; Email: constantinescu.catalin@ymail.com
• Study Contact Backup: Name: Olga Grajdieru, MD; Email: olgadoinag@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Recruiting
      • Emergency County Clinical Hospital
      • Contact: Catalin Constantinescu, MD, PhD; Phone Number: 0040743903224; Email: constantinescu.catalin@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Procedure difficulty	(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible	During PDT (an expected average of 15-30 minutes)
ICU mortality	We will measure ICU mortality at the discharge and 60 days after discharge.	During hospital LOS (an expected average of 4 weeks )
Hospital mortality	We will measure hospital mortality at the discharge and 60 days after discharge.	During hospital LOS (an expected average of 4 weeks)
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)
Mechanical ventilation	Days of MV before and after PDT	During hospital LOS (an expected average of 4 weeks)
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)
Minor complication - Accidental decannulation	Accidental decannulation	During hospital LOS (an expected average of 4 weeks)
Minor complication - Tracheostomy stoma infection	Tracheostomy stoma infection	During hospital LOS (an expected average of 4 weeks)
Minor complication - Localized minor bleeding	Localized minor bleeding	During PDT (an expected average of 15-30 minutes)
Minor complication - Localized subcutaneous emphysema	Localized subcutaneous emphysema	During PDT (an expected average of 15-30 minutes)
Lenght of ICU stay	Lenght of ICU stay	(an expected average of 4 weeks)
Lenght of hospital stay	Lenght of hospital stay	(an expected average of 4 weeks)

Collaborators and Investigators

• Sponsor: Universitatea de Medicina si Farmacie Iuliu Hatieganu
• Investigators: Study Chair: Cristina Petrisor, Prof, Universitatea de Medicina si Farmacie Iuliu Hatieganu

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): January 6, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: UMF-USBR-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No