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

NCT ID: NCT06226142

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tracheostomy Complication Tracheostomy Infection Tracheostomy Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ultrasound guided percutaneous tracheostomy

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

Group Type EXPERIMENTAL

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy

Bronchoscopy guided percutaneous tracheostomy

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

Group Type ACTIVE_COMPARATOR

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy

Ultrasound-bronchoscopy guided percutaneous tracheostomy

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

Group Type ACTIVE_COMPARATOR

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Percutaneous dilatational tracheostomy

Interventions

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Percutaneous dilatational tracheostomy

Percutaneous dilatational tracheostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Constantinescu Catalin

Assistant lecturer, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina Petrisor, Prof

Role: STUDY_CHAIR

Iuliu Hatieganu University of Medicine and Pharmacy

Locations

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Emergency County Clinical Hospital

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Catalin Constantinescu, MD, PhD

Role: CONTACT

0040743903224

Olga Grajdieru, MD

Role: CONTACT

Facility Contacts

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Catalin Constantinescu, MD, PhD

Role: primary

0040743903224

Other Identifiers

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UMF-USBR-2024-001

Identifier Type: -

Identifier Source: org_study_id

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