Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures (BRONCHOPROEM)

March 11, 2024 updated by: Vitaz

'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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Out-of-hospital care

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bronchoscopy under local anesthesia
Other: no intervention
only observational
Bronchoscopy under anxiolysis
Other: no intervention
only observational
Bronchoscopy under conscious sedation
Other: no intervention
only observational
Bronchoscopy under general anesthesia
Other: no intervention
only observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related dyspnea scale (VAS)
Time Frame: 24 hours
Procedure-related dyspnea scale (VAS)
24 hours
Procedure-related pain scale (VAS)
Time Frame: 24 hours
Procedure-related pain scale (VAS)
24 hours
Procedure related cough scale (VAS)
Time Frame: 24 hours
Procedure related cough scale (VAS)
24 hours
General patient satisfaction
Time Frame: 24 hours
General patient satisfaction VAS scale
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitaz

Investigators

  • Principal Investigator: Jonas Yserbyt, MD, PhD, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 23022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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