Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Emphysema or COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205826
• Other study ID #: CHARTIS sedation
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: April 2019
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 )

Related Conditions & MeSH terms

• Emphysema
• Emphysema or COPD
• Pulmonary Emphysema

Intervention

Other:
• Type 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate	The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.	Baseline
Secondary	Chartis measurement duration	To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia.	Baseline
Secondary	Physician feasibility	To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia.	Baseline
Secondary	Influence severity on outcome	To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia.	Baseline
Secondary	Influence collateral ventilation status on outcome	To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia	Baseline

External Links

•   Website bronchoscopy center UMCG