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OpenTrials
Completed

NCT Number: NCT03205826

Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Type of sedation used

Other

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 outcomes

  1. Failure rate

    Time frame: Baseline

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

Secondary outcomes

  1. Chartis measurement duration

    Time frame: Baseline

    To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia.

  2. Physician feasibility

    Time frame: Baseline

    To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia.

  3. Influence severity on outcome

    Time frame: Baseline

    To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia.

  4. Influence collateral ventilation status on outcome

    Time frame: Baseline

    To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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