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Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Primary Purpose

Emphysema or COPD

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Type of sedation used
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Emphysema or COPD focused on measuring Emphysema, Bronchoscopic intervention, CHARTIS measurement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 )

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Type of sedation used

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2017
Last Updated
April 16, 2019
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03205826
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema or COPD
Keywords
Emphysema, Bronchoscopic intervention, CHARTIS measurement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type of sedation used
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Type of sedation used
Intervention 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.
Primary Outcome Measure Information:
Title
Failure rate
Description
The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Chartis measurement duration
Description
To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia.
Time Frame
Baseline
Title
Physician feasibility
Description
To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia.
Time Frame
Baseline
Title
Influence severity on outcome
Description
To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia.
Time Frame
Baseline
Title
Influence collateral ventilation status on outcome
Description
To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: FEV1 <20% RV/TLC>70% pCO2 >6.5 RVSP>40mmHg 6MWT<200m Known intolerance to Lidocaine Any other medical reason/condition that warrants a short procedure (physician judgement )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk-Jan Slebos, MD PhD
Organizational Affiliation
d.j.slebos@umcg.nl
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
31421111
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.
Results Reference
derived

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Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

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