NCT06307379

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 13, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

October 9, 2023

Last Update Submit

March 11, 2024

Conditions

Bronchial Diseases

Keywords

bronchoscopyendoscopypatient reported outcome measures

Outcome Measures

Primary Outcomes (4)

  • Procedure-related dyspnea scale (VAS)

    Procedure-related dyspnea scale (VAS)

    24 hours

  • Procedure-related pain scale (VAS)

    Procedure-related pain scale (VAS)

    24 hours

  • Procedure related cough scale (VAS)

    Procedure related cough scale (VAS)

    24 hours

  • General patient satisfaction

    General patient satisfaction VAS scale

    24 hours

Secondary Outcomes (3)

  • Procedure-related complications:

    24 hours

  • Sedation-related complications

    24 hours

  • Diagnostic yield

    30 days

Study Arms (4)

Bronchoscopy under local anesthesia

Bronchoscopy under local anesthesia

Other: no intervention

Bronchoscopy under anxiolysis

Bronchoscopy under anxiolysis

Other: no intervention

Bronchoscopy under conscious sedation

Bronchoscopy under conscious sedation

Other: no intervention

Bronchoscopy under general anesthesia

Bronchoscopy under general anesthesia

Other: no intervention

Interventions

no interventionOTHER

only observational

Bronchoscopy under anxiolysisBronchoscopy under conscious sedationBronchoscopy under general anesthesiaBronchoscopy under local anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Out-of-hospital care

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VITAZ

Sint-Niklaas, Belgium

RECRUITING

MeSH Terms

Conditions

Bronchial Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Jonas Yserbyt, MD, PhD

    MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Yserbyt, MD,PhD

CONTACT

+3237602327jonas.yserbyt@vitaz.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

March 12, 2024

Study Start

February 13, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)