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Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06307379
Acronym
BRONCHOPROEM
Enrollment
300
Registered
2024-03-12
Start date
2024-02-13
Completion date
2025-12-30
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Diseases

Keywords

bronchoscopy, endoscopy, patient reported outcome measures

Brief summary

'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: 1. Quality improvement within the current clinical care structure 2. Monitoring the health status of the population 3. Contribution to decision-making regarding financing of care 4. Increase employee and patient involvement in clinical care pathways 5. Rationalize the deployment of medical personnel and resources 6. Integration of data in electronic patient files and registers

Interventions

OTHERno intervention

only observational

Sponsors

Vitaz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age above 18 years * Patient referred for diagnostic flexible bronchoscopy * Procedure performed in outpatient setting

Exclusion criteria

* Patient unable to adequately respond to the contents of the patient questionnaire. * Procedure performed in hospitalised setting * Patient with active pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Procedure-related dyspnea scale (VAS)24 hoursProcedure-related dyspnea scale (VAS)
Procedure-related pain scale (VAS)24 hoursProcedure-related pain scale (VAS)
Procedure related cough scale (VAS)24 hoursProcedure related cough scale (VAS)
General patient satisfaction24 hoursGeneral patient satisfaction VAS scale

Secondary

MeasureTime frameDescription
Sedation-related complications24 hoursparadoxical agitation; GCS; hypoxaemia; hypercapnia
Diagnostic yield30 daysnumber of biopsies; histological diagnosis; DNA extraction.
Procedure-related complications:24 hoursbleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate.

Countries

Belgium

Contacts

Primary ContactJonas Yserbyt, MD,PhD
jonas.yserbyt@vitaz.be+3237602327

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026