Tracheostomy ComplicationBRONCUS-PDTNCT06226142
The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial
A study testing Percutaneous dilatational tracheostomy in people with Tracheostomy Complication and Tracheostomy Infection, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy Complication, Tracheostomy Infection, Tracheostomy Hemorrhage
- What is being tested?
- Percutaneous dilatational tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 17 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Olga Grajdieru, MD contact
Romania1 site, 1 recruiting
- Recruiting
Emergency County Clinical Hospital
Cluj-Napoca, Cluj, 400006
Catalin Constantinescu, MD, PhD, 0040743903224, constantinescu.catalin@ymail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Percutaneous dilatational tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous dilatational tracheostomyProcedure or surgery
Percutaneous dilatational tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided percutaneous tracheostomy | Experimental | The PDT will be performed by the attending physician exclusively with the aid of the ultrasound. Receives: 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. Receives: 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. Receives: Procedure: Percutaneous dilatational tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During PDT - 15-25 minutes
Secondary outcomes (13)
Minor complication - hypotension
a drop of MAP<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors
Measured: During PDT (an expected average of 15-30 minutes)
Procedure difficulty
(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible
Measured: During PDT (an expected average of 15-30 minutes)
ICU mortality
We will measure ICU mortality at the discharge and 60 days after discharge.
Measured: During hospital LOS (an expected average of 4 weeks )
Hospital mortality
We will measure hospital mortality at the discharge and 60 days after discharge.
Measured: 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.
Measured: During PDT (an expected average of 15-30 minutes)
Mechanical ventilation
Days of MV before and after PDT
Measured: 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
Measured: During PDT (an expected average of 15-30 minutes)
Minor complication - Accidental decannulation
Accidental decannulation
Measured: During hospital LOS (an expected average of 4 weeks)
Minor complication - Tracheostomy stoma infection
Tracheostomy stoma infection
Measured: During hospital LOS (an expected average of 4 weeks)
Minor complication - Localized minor bleeding
Localized minor bleeding
Measured: During PDT (an expected average of 15-30 minutes)
Minor complication - Localized subcutaneous emphysema
Localized subcutaneous emphysema
Measured: During PDT (an expected average of 15-30 minutes)
Lenght of ICU stay
Lenght of ICU stay
Measured: (an expected average of 4 weeks)
Lenght of hospital stay
Lenght of hospital stay
Measured: (an expected average of 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start17 Jan 2024
- Primary completion6 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinescu Catalin, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Cristina Petrisor, Prof, Study chair, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226142
- Sponsor's protocol ID
- UMF-USBR-2024-001
- Acronym
- BRONCUS-PDT
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasound-guided Versus Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Dilational Tracheostomy Trial - Standardization or Customization?
- ClinicalTrials.gov ID
- NCT06226142
- Acronym / sponsor ID
- BRONCUS-PDT / UMF-USBR-2024-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 6 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided percutaneous tracheostomy | Experimental | Procedure: Percutaneous dilatational tracheostomyThe PDT will be performed by the attending physician exclusively with the aid of the ultrasound. |
| Bronchoscopy guided percutaneous tracheostomy | Active comparator | Procedure: Percutaneous dilatational tracheostomyThe PDT will be performed by the attending physician exclusively with the aid of the bronchoscope. |
| Ultrasound-bronchoscopy guided percutaneous tracheostomy | Active comparator | Procedure: Percutaneous dilatational tracheostomyThe PDT will be performed by the attending physician with the aid of the ultrasound and bronchoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
Key exclusion criteria (8 listed)
- short neck
- tracheal deviation
- difficult anatomy
- previous neck surgery
- cervical trauma or inability to perform neck extension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous dilatational tracheostomyPercutaneous dilatational tracheostomy | Procedure or surgery | Bronchoscopy guided percutaneous tracheostomy, Ultrasound guided percutaneous tracheostomy, Ultrasound-bronchoscopy guided percutaneous tracheostomy |
Primary outcome
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.
13 secondary outcomes
Minor complication - hypotension
Time frame: During PDT (an expected average of 15-30 minutes)
Procedure difficulty
Time frame: During PDT (an expected average of 15-30 minutes)
ICU mortality
Time frame: During hospital LOS (an expected average of 4 weeks )
Hospital mortality
Time frame: During hospital LOS (an expected average of 4 weeks)
Procedure duration
Time frame: During PDT (an expected average of 15-30 minutes)
Mechanical ventilation
Time frame: During hospital LOS (an expected average of 4 weeks)
Minor complication - hypoxemia
Time frame: During PDT (an expected average of 15-30 minutes)
Minor complication - Accidental decannulation
Time frame: 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)
Minor complication - Localized minor bleeding
Time frame: 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)
Lenght of ICU stay
Time frame: (an expected average of 4 weeks)
Lenght of hospital stay
Time frame: (an expected average of 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Grajdieru, MD contact
Cristina Petrisor, Prof study chair
Iuliu Hatieganu University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous dilatational tracheostomy in people with Tracheostomy Complication and Tracheostomy Infection, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catalin Constantinescu, MD, PhD (0040743903224, constantinescu.catalin@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDT feasibility/failure (time frame: During PDT - 15-25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.