Measuring collateral ventilation using Chartis® to select patients with severe emphysema for endobronchial valve treatment: conscious sedation versus general anesthesia

Completed

• Conditions: Lung disease; 10038716; Emphysema

• Registration Number: NL-OMON46522
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
-Patient has provided signed informed consent.

Exclusion Criteria

1) FEV1 < 20%
2) RV/TLC>70%
3) pCO2 >6.5
4) RVSP>40mmHg
5) 6MWT<200m
6) Known intolerance to Lidocaine
7) Any other medical reason/condition that warrants a short procedure ( physician judgement )

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>1. To compare the duration of Chartis measurement in patients undergoing<br /><br>conscious sedation versus general anesthesia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br><br /><br>2. The failure rate of the Chartis collateral ventilation measurement under<br /><br>general anesthesia versus conscious sedation<br /><br><br /><br>3. To investigate qualitative assessment feasibility for the physician in<br /><br>patients undergoing conscious sedation or general anesthesia.<br /><br><br /><br>4. To investigate the influence of severity of disease in patients undergoing<br /><br>conscious sedation or general anesthesia.<br /><br><br /><br>5. To investigate outcome difference in collateral ventilation status in<br /><br>patients undergoing conscious sedation versus general anesthesia</p><br>