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Clinical Trials/NCT06307379
NCT06307379
Recruiting
N/A

Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Vitaz1 site in 1 country300 target enrollmentFebruary 13, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bronchial Diseases
Sponsor
Vitaz
Enrollment
300
Locations
1
Primary Endpoint
Procedure-related pain scale (VAS)
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 13, 2024
End Date
December 30, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Vitaz
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Procedure-related pain scale (VAS)

Time Frame: 24 hours

Procedure-related pain scale (VAS)

Procedure-related dyspnea scale (VAS)

Time Frame: 24 hours

Procedure-related dyspnea 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

Secondary Outcomes

  • Sedation-related complications(24 hours)
  • Procedure-related complications:(24 hours)
  • Diagnostic yield(30 days)

Study Sites (1)

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