NCT06226142

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 5, 2024

Last Update Submit

January 17, 2024

Conditions

Tracheostomy ComplicationTracheostomy InfectionTracheostomy Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Minor complication - hypotension

    During PDT (an expected average of 15-30 minutes)

  • Procedure difficulty

    During PDT (an expected average of 15-30 minutes)

  • ICU mortality

    During hospital LOS (an expected average of 4 weeks )

  • Hospital mortality

    During hospital LOS (an expected average of 4 weeks)

  • Procedure duration

    During PDT (an expected average of 15-30 minutes)

  • +8 more secondary outcomes

Study Arms (3)

Ultrasound guided percutaneous tracheostomy

EXPERIMENTAL

The PDT will be performed by the attending physician exclusively with the aid of the ultrasound.

Procedure: Percutaneous dilatational tracheostomy

Bronchoscopy guided percutaneous tracheostomy

ACTIVE COMPARATOR

The PDT will be performed by the attending physician exclusively with the aid of the bronchoscope.

Procedure: Percutaneous dilatational tracheostomy

Ultrasound-bronchoscopy guided percutaneous tracheostomy

ACTIVE COMPARATOR

The PDT will be performed by the attending physician with the aid of the ultrasound and bronchoscope.

Procedure: Percutaneous dilatational tracheostomy

Interventions

Percutaneous dilatational tracheostomyPROCEDURE

Percutaneous dilatational tracheostomy

Bronchoscopy guided percutaneous tracheostomyUltrasound guided percutaneous tracheostomyUltrasound-bronchoscopy guided percutaneous tracheostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency County Clinical Hospital

Cluj-Napoca, Cluj, 400006, Romania

RECRUITING

Study Officials

  • Cristina Petrisor, Prof

    Iuliu Hatieganu University of Medicine and Pharmacy

    STUDY CHAIR

Central Study Contacts

Catalin Constantinescu, MD, PhD

CONTACT

0040743903224constantinescu.catalin@ymail.com

Olga Grajdieru, MD

CONTACT

olgadoinag@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, PhD

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 26, 2024

Study Start

January 17, 2024

Primary Completion

January 6, 2025

Study Completion

January 1, 2026

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)