## Protocol Section
### Identification Module
**NCT ID:** NCT06307379

**Acronym:** BRONCHOPROEM

**Brief Title:** Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

**Official Title:** Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

#### Organization Study ID Info
**ID:** EC 23022
#### Organization
**Class:** OTHER
**Full Name:** Vitaz
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-13

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-03-12
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-09
**Study First Submit QC Date:** 2024-03-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Vitaz

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Bronchial Diseases

**Keywords:**

- bronchoscopy

- endoscopy

- patient reported outcome measures

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bronchoscopy under local anesthesia

**Intervention Names:**

- Other: no intervention

**Label:** Bronchoscopy under local anesthesia

#### Arm Group 2

**Description:** Bronchoscopy under anxiolysis

**Intervention Names:**

- Other: no intervention

**Label:** Bronchoscopy under anxiolysis

#### Arm Group 3

**Description:** Bronchoscopy under conscious sedation

**Intervention Names:**

- Other: no intervention

**Label:** Bronchoscopy under conscious sedation

#### Arm Group 4

**Description:** Bronchoscopy under general anesthesia

**Intervention Names:**

- Other: no intervention

**Label:** Bronchoscopy under general anesthesia

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bronchoscopy under anxiolysis

- Bronchoscopy under conscious sedation

- Bronchoscopy under general anesthesia

- Bronchoscopy under local anesthesia

**Description:** only observational

**Name:** no intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Procedure-related dyspnea scale (VAS)

**Measure:** Procedure-related dyspnea scale (VAS)

**Time Frame:** 24 hours

**Description:** Procedure-related pain scale (VAS)

**Measure:** Procedure-related pain scale (VAS)

**Time Frame:** 24 hours

**Description:** Procedure related cough scale (VAS)

**Measure:** Procedure related cough scale (VAS)

**Time Frame:** 24 hours

**Description:** General patient satisfaction VAS scale

**Measure:** General patient satisfaction

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** bleeding + grading; pneumothorax; hypoxaemia; hypercapnia; respiratory rate; heart rate.

**Measure:** Procedure-related complications:

**Time Frame:** 24 hours

**Description:** paradoxical agitation; GCS; hypoxaemia; hypercapnia

**Measure:** Sedation-related complications

**Time Frame:** 24 hours

**Description:** number of biopsies; histological diagnosis; DNA extraction.

**Measure:** Diagnostic yield

**Time Frame:** 30 days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Out-of-hospital care

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jonas.yserbyt@vitaz.be

**Name:** Jonas Yserbyt, MD,PhD

**Phone:** +3237602327

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sint-Niklaas

**Contacts:**

***Contact 1:***

- **Email:** jonas.yserbyt@vitaz.be

- **Name:** Jonas Yserbyt

- **Role:** CONTACT

**Country:** Belgium

**Facility:** VITAZ

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** MD

**Name:** Jonas Yserbyt, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5258

- Name: Bronchial Diseases

- Relevance: HIGH

- As Found: Bronchial Diseases

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001982

- Term: Bronchial Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
