Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Emphysema or COPD

Treatments: Other: Type of sedation used

Study type: Interventional

Funder types: Other

Identifiers

NCT03205826

CHARTIS sedation

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: No 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 )

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Type of sedation used

Other group

Description:

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.

Treatment:

Other: Type of sedation used