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.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
1. To compare the duration of Chartis measurement in patients undergoing
conscious sedation versus general anesthesia.
Secondary outcome
Secondary Objectives:
2. The failure rate of the Chartis collateral ventilation measurement under
general anesthesia versus conscious sedation
3. To investigate qualitative assessment feasibility for the physician in
patients undergoing conscious sedation or general anesthesia.
4. To investigate the influence of severity of disease in patients undergoing
conscious sedation or general anesthesia.
5. To investigate outcome difference in collateral ventilation status in
patients undergoing conscious sedation versus general anesthesia
Background summary
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.
Study 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 burden and risks
Risks associated with our study include the risks associated with an additional
Chartis measurement and a longer duration of the bronchoscopy and anesthesia
(approximately 15 minutes). There are no additionally scheduled screening,
baseline or follow-up visits.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
-Patient has provided signed informed consent.
Exclusion criteria
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 )
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03205826 |
| CCMO | NL62374.042.17 |