Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Not Applicable

Completed

• Conditions: Emphysema or COPD
• Interventions: Other: Type of sedation used

• Registration Number: NCT03205826
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Study Start: 2018-03-01
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
• Patient has provided signed informed consent.

Read More

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 )

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type of sedation used	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.

Primary Outcome Measures

Name	Time	Method
Failure rate	Baseline	The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

Secondary Outcome Measures

Name	Time	Method
Influence collateral ventilation status on outcome	Baseline	To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia
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.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands