Clinical trial NCT03205826: Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia
Official title: Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema or COPD
Keywords: Emphysema
Bronchoscopic intervention
CHARTIS measurement
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 )

Primary outcomes:
measure: Failure rate
timeFrame: Baseline
Secondary outcomes:
measure: Chartis measurement duration
timeFrame: Baseline
measure: Physician feasibility
timeFrame: Baseline
measure: Influence severity on outcome
timeFrame: Baseline
measure: Influence collateral ventilation status on outcome
timeFrame: Baseline
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: d.j.slebos@umcg.nl
name: Dirk-Jan Slebos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welling JBA, Klooster K, Hartman JE, Kerstjens HAM, Franz I, Struys MMRF, Absalom AR, Slebos DJ, Barends CRM. Collateral Ventilation Measurement Using Chartis: Procedural Sedation vs General Anesthesia. Chest. 2019 Nov;156(5):984-990. doi: 10.1016/j.chest.2019.07.025. Epub 2019 Aug 15.