Bronchial DiseasesBRONCHOPROEMNCT06307379
Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures
An observational study of Bronchial Diseases, run by Vitaz at 1 site in Belgium.
Trial summary
'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Diseases
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Feb 2024to 30 Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Out-of-hospital care
Who may be able to join
- Age above 18 years
- Patient referred for diagnostic flexible bronchoscopy
- Procedure performed in outpatient setting
Who cannot join
- Patient unable to adequately respond to the contents of the patient questionnaire.
- Procedure performed in hospitalised setting
- Patient with active pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
VITAZ
Sint-Niklaas
Jonas Yserbyt, jonas.yserbyt@vitaz.be
About this study
'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.
Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.
Read the detailed description
The potential usefulness of PROM/PREMS is multiple:
- Quality improvement within the current clinical care structure
- Monitoring the health status of the population
- Contribution to decision-making regarding financing of care
- Increase employee and patient involvement in clinical care pathways
- Rationalize the deployment of medical personnel and resources
- Integration of data in electronic patient files and registers
- Conditions
- Bronchial Diseases
- Being tested
- no intervention
- Keywords
- bronchoscopy, endoscopy, patient reported outcome measures
- Medical subject headings
- Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
only observational
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy under local anesthesia | Bronchoscopy under local anesthesia Receives: Other: no intervention | |
| Bronchoscopy under anxiolysis | Bronchoscopy under anxiolysis Receives: Other: no intervention | |
| Bronchoscopy under conscious sedation | Bronchoscopy under conscious sedation Receives: Other: no intervention | |
| Bronchoscopy under general anesthesia | Bronchoscopy under general anesthesia Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related dyspnea scale (VAS)
Procedure-related dyspnea scale (VAS)
Measured: 24 hours
Procedure-related pain scale (VAS)
Procedure-related pain scale (VAS)
Measured: 24 hours
Procedure related cough scale (VAS)
Procedure related cough scale (VAS)
Measured: 24 hours
General patient satisfaction
General patient satisfaction VAS scale
Measured: 24 hours
Secondary outcomes (3)
Procedure-related complications:
bleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate.
Measured: 24 hours
Sedation-related complications
paradoxical agitation; GCS; hypoxaemia; hypercapnia
Measured: 24 hours
Diagnostic yield
number of biopsies; histological diagnosis; DNA extraction.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start13 Feb 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Yserbyt, MD, PhD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307379
- Sponsor's protocol ID
- EC 23022
- Acronym
- BRONCHOPROEM
- Status last verified
- Mar 2024
- First submitted
- 9 Oct 2023
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures
- ClinicalTrials.gov ID
- NCT06307379
- Acronym / sponsor ID
- BRONCHOPROEM / EC 23022
- Conditions
- Bronchial Diseases
- Keywords
- bronchoscopy, endoscopy, patient reported outcome measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- VitazUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Mar 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.
'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.
Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.
Detailed description
The potential usefulness of PROM/PREMS is multiple:
- Quality improvement within the current clinical care structure
- Monitoring the health status of the population
- Contribution to decision-making regarding financing of care
- Increase employee and patient involvement in clinical care pathways
- Rationalize the deployment of medical personnel and resources
- Integration of data in electronic patient files and registers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy under local anesthesia | – | Other: no interventionBronchoscopy under local anesthesia |
| Bronchoscopy under anxiolysis | – | Other: no interventionBronchoscopy under anxiolysis |
| Bronchoscopy under conscious sedation | – | Other: no interventionBronchoscopy under conscious sedation |
| Bronchoscopy under general anesthesia | – | Other: no interventionBronchoscopy under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Out-of-hospital care
Key inclusion criteria (3 listed)
- Age above 18 years
- Patient referred for diagnostic flexible bronchoscopy
- Procedure performed in outpatient setting
Key exclusion criteria (3 listed)
- Patient unable to adequately respond to the contents of the patient questionnaire.
- Procedure performed in hospitalised setting
- Patient with active pregnancy
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 |
|---|---|---|
| no interventiononly observational | Other | Bronchoscopy under anxiolysis, Bronchoscopy under conscious sedation, Bronchoscopy under general anesthesia, Bronchoscopy under local anesthesia |
Primary outcome
Procedure-related dyspnea scale (VAS)
Time frame: 24 hours
Procedure-related dyspnea scale (VAS)
Procedure-related pain scale (VAS)
Time frame: 24 hours
Procedure-related pain scale (VAS)
Procedure related cough scale (VAS)
Time frame: 24 hours
Procedure related cough scale (VAS)
General patient satisfaction
Time frame: 24 hours
General patient satisfaction VAS scale
3 secondary outcomes
Procedure-related complications:
Time frame: 24 hours
Sedation-related complications
Time frame: 24 hours
Diagnostic yield
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchial Diseases
Recruiting
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Lung Neoplasm
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
Active, not recruitingPhase 3
Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Asthma
RecruitingPhase 4
Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.
Non-small Cell Lung Cancer
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.
Jonas Yserbyt, MD, PhD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Diseases, run by Vitaz at 1 site in Belgium.
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 3 inclusion and 3 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 12 Mar 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 Belgium. 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 Jonas Yserbyt, MD,PhD (+3237602327, jonas.yserbyt@vitaz.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related dyspnea scale (VAS) (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 12 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.