University Medical Center Groningen
Groningen, Netherlands
NCT Number: NCT03205826
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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Interventional
Not applicable
Groningen, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For safety reasons patients that meet the following criteria will not be included in this study:
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.
Time frame: Baseline
The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
Time frame: Baseline
To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia.
Time frame: Baseline
To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia.
Time frame: Baseline
To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia.
Time frame: Baseline
To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia
University Medical Center Groningen
Other
Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia
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