Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Recruiting

• Conditions: Bronchial Diseases
• Interventions: Other: no intervention

• Registration Number: NCT06307379
• Lead Sponsor: Vitaz

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

Study Timeline

• Study First Submitted: 2023-10-09
• Study Start: 2024-02-13
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchoscopy under anxiolysis	no intervention	Bronchoscopy under anxiolysis
Bronchoscopy under local anesthesia	no intervention	Bronchoscopy under local anesthesia
Bronchoscopy under conscious sedation	no intervention	Bronchoscopy under conscious sedation
Bronchoscopy under general anesthesia	no intervention	Bronchoscopy under general anesthesia

Primary Outcome Measures

Name	Time	Method
Procedure related cough scale (VAS)	24 hours	Procedure related cough scale (VAS)
General patient satisfaction	24 hours	General patient satisfaction VAS scale
Procedure-related pain scale (VAS)	24 hours	Procedure-related pain scale (VAS)
Procedure-related dyspnea scale (VAS)	24 hours	Procedure-related dyspnea scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Sedation-related complications	24 hours	paradoxical agitation; GCS; hypoxaemia; hypercapnia
Procedure-related complications:	24 hours	bleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate.
Diagnostic yield	30 days	number of biopsies; histological diagnosis; DNA extraction.

Trial Locations

Locations (1)

VITAZ; 🇧🇪 Sint-Niklaas, Belgium