Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Bronchial Diseases Clinical Trial

— BRONCHOPROEM  

Official title:

Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307379
• Other study ID #: EC 23022
• Status: Recruiting
• Start date: February 13, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Vitaz
• Contact: Jonas Yserbyt, MD,PhD
• Phone: +3237602327
• Email: jonas.yserbyt[@]vitaz.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Diseases

Intervention

Other:
• no intervention
only observational

Locations

Country	Name	City	State
Belgium	VITAZ	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
Vitaz

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related dyspnea scale (VAS)	Procedure-related dyspnea scale (VAS)	24 hours
Primary	Procedure-related pain scale (VAS)	Procedure-related pain scale (VAS)	24 hours
Primary	Procedure related cough scale (VAS)	Procedure related cough scale (VAS)	24 hours
Primary	General patient satisfaction	General patient satisfaction VAS scale	24 hours
Secondary	Procedure-related complications:	bleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate.	24 hours
Secondary	Sedation-related complications	paradoxical agitation; GCS; hypoxaemia; hypercapnia	24 hours
Secondary	Diagnostic yield	number of biopsies; histological diagnosis; DNA extraction.	30 days