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Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

NCT03205826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-17

No results posted yet for this study

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.

Conditions

  • Emphysema or COPD

Interventions

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-01-22
Completion
2019-01-22

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205826 on ClinicalTrials.gov