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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate | The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Chartis measurement duration | To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia. | Baseline |
| Physician feasibility | To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
For safety reasons patients that meet the following criteria will not be included in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD PhD | d.j.slebos@umcg.nl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31421111 | Derived | 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. |
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No plan to share IPD
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline |
| Influence severity on outcome | To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia. | Baseline |
| Influence collateral ventilation status on outcome | To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia | Baseline |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |