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

January 17, 2024 updated by: Constantinescu Catalin, Universitatea de Medicina si Farmacie Iuliu Hatieganu

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PDT feasibility/failure
Time Frame: During PDT - 15-25 minutes
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minor complication - hypotension
Time Frame: During PDT (an expected average of 15-30 minutes)
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
Time Frame: During PDT (an expected average of 15-30 minutes)
(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible
During PDT (an expected average of 15-30 minutes)
ICU mortality
Time Frame: During hospital LOS (an expected average of 4 weeks )
We will measure ICU mortality at the discharge and 60 days after discharge.
During hospital LOS (an expected average of 4 weeks )
Hospital mortality
Time Frame: During hospital LOS (an expected average of 4 weeks)
We will measure hospital mortality at the discharge and 60 days after discharge.
During hospital LOS (an expected average of 4 weeks)
Procedure duration
Time Frame: During PDT (an expected average of 15-30 minutes)
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
Time Frame: During hospital LOS (an expected average of 4 weeks)
Days of MV before and after PDT
During hospital LOS (an expected average of 4 weeks)
Minor complication - hypoxemia
Time Frame: During PDT (an expected average of 15-30 minutes)
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
Time Frame: During hospital LOS (an expected average of 4 weeks)
Accidental decannulation
During hospital LOS (an expected average of 4 weeks)
Minor complication - Tracheostomy stoma infection
Time Frame: During hospital LOS (an expected average of 4 weeks)
Tracheostomy stoma infection
During hospital LOS (an expected average of 4 weeks)
Minor complication - Localized minor bleeding
Time Frame: During PDT (an expected average of 15-30 minutes)
Localized minor bleeding
During PDT (an expected average of 15-30 minutes)
Minor complication - Localized subcutaneous emphysema
Time Frame: During PDT (an expected average of 15-30 minutes)
Localized subcutaneous emphysema
During PDT (an expected average of 15-30 minutes)
Lenght of ICU stay
Time Frame: (an expected average of 4 weeks)
Lenght of ICU stay
(an expected average of 4 weeks)
Lenght of hospital stay
Time Frame: (an expected average of 4 weeks)
Lenght of hospital stay
(an expected average of 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitatea de Medicina si Farmacie Iuliu Hatieganu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cristina Petrisor, Prof, Universitatea de Medicina si Farmacie Iuliu Hatieganu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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