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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
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.
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
RECRUITINGConfirmation 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.
Time frame: during the intervention
Acquisition of at least one histological sample
Time frame: during the intervention
histopathological classification of the pulmonary lesion
Time frame: From enrollment to the end of treatment at 8 days.
Procedure duration
Time frame: during the intervention
Diagnostic yield of biopsies
According to the ATS2024 strict consensus criteria (https://doi.org/10.1164/rccm.202401-0192ST)
Time frame: From enrollment to the end of treatment at 8 days.
diagnostic accuracy for malignancy
Biopsies with definitive malignancy/Cases with proven malignance over the course of 3 months
Time frame: From enrollment to the end of treatment of 3 months
cost analysis
Total billed costs in CHF for the bronchoscopy excl. anesthesia
Time frame: 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.
Time frame: From enrollment to the end of treatment at 8 days.
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