Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03205826

Enrollment

Registered

2017-07-02

Start date

2018-03-01

Completion date

2019-01-22

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema or COPD

Keywords

Emphysema, Bronchoscopic intervention, CHARTIS measurement

Brief summary

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.

Interventions

OTHERType of sedation used

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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: 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 )

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026