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In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted bronchoscopy with Propofol | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted bronchoscopy under propofol | Device | In this study, patients will undergo a robotic-assisted bronchoscopy under moderate sedation with propofol. While the use of propofol as a sedative is common for manual bronchoscopies, robotic-assisted bronchoscopy is only permitted under general anesthesia. In the study intervention, the investigators want to test the feasibility of the combination of robotic-assisted bronchoscopy under propofol. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of tool-in-lesion | Composite outcome defined as meeting at least one of the following criteria: 1) Radiological confirmation of the biopsy tool located within the target lung lesion using cone-beam CT. 2) Positive signal on radial endobronchial ultrasound (rEBUS) indicating the lesion was reached. 3) Pathological confirmation of specific malignant or benign tissue in the biopsy sample. | during the intervention |
| Acquisition of at least one histological sample | during the intervention | |
| histopathological classification of the pulmonary lesion | From enrollment to the end of treatment at 8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | during the intervention | |
| Diagnostic yield of biopsies | According to the ATS2024 strict consensus criteria (https://doi.org/10.1164/rccm.202401-0192ST) | From enrollment to the end of treatment at 8 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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Pilot study
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| diagnostic accuracy for malignancy | Biopsies with definitive malignancy/Cases with proven malignance over the course of 3 months | From enrollment to the end of treatment of 3 months |
| cost analysis | Total billed costs in CHF for the bronchoscopy excl. anesthesia | From enrollment to the end of treatment at 8 days. |
| Safety profile | Rate of pneumothoraces, bleeding rates (Nashville Classification Grad >2), and rate of unplanned hospitalizations >5 days. | From enrollment to the end of treatment at 8 days. |