Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Study Overview
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Brief Summary
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Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature. Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia. Study design: This study will be a single center observational study Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves. Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

Official Title
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Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia

Conditions
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Emphysema or COPD

Intervention / Treatment
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* Other: Type of sedation used


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves Patient has provided signed informed consent. Exclusion Criteria: For safety reasons patients that meet the following criteria will not be included in this study: FEV1 <20% RV/TLC>70% pCO2 >6.5 RVSP>40mmHg 6MWT<200m Known intolerance to Lidocaine Any other medical reason/condition that warrants a short procedure (physician judgement )
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type of sedation used<br>All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. | Other: Type of sedation used<br>* All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate | The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chartis measurement duration | To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia. | Baseline | 
| Physician feasibility | To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia. | Baseline | 
| Influence severity on outcome | To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia. | Baseline | 
| Influence collateral ventilation status on outcome | To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, Bronchoscopic intervention, CHARTIS measurement