Bronchoscopy, Bronchoscopy Biopsy, Lung Lesions, Propofol, Robotic Assisted Bronchoscopy
Conditions
Keywords
Robotic-assisted bronchoscopy, robotic assisted bronchoscopy, diagnosis of lung lesions, moderate sedation
Brief summary
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.
Interventions
DEVICERobotic-assisted bronchoscopy under propofol
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.
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent signed by the subject * aged at least 18 years * scheduled for bronchoscopy with moderate sedation and tracheal intubation in order to obtain at least 1 specimens of the lung via transbronchial biopsy * necessary periinterventional laboratory examinations needed for the bronchoscopy * judgement of the subject
Exclusion criteria
* endobronchial lesion causing lobar atelectasis * inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders or severe neurosis) * pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of tool-in-lesion | during the intervention | 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. |
| 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. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration | during the intervention | — |
| Diagnostic yield of biopsies | From enrollment to the end of treatment at 8 days. | According to the ATS2024 strict consensus criteria (https://doi.org/10.1164/rccm.202401-0192ST) |
| diagnostic accuracy for malignancy | From enrollment to the end of treatment of 3 months | Biopsies with definitive malignancy/Cases with proven malignance over the course of 3 months |
| cost analysis | From enrollment to the end of treatment at 8 days. | Total billed costs in CHF for the bronchoscopy excl. anesthesia |
| Safety profile | From enrollment to the end of treatment at 8 days. | Rate of pneumothoraces, bleeding rates (Nashville Classification Grad \>2), and rate of unplanned hospitalizations \>5 days. |
Countries
Switzerland
Outcome results
None listed