Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Robotic-assisted bronchoscopy under propofol
DeviceIn 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Robotic-assisted bronchoscopy with PropofolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
during the intervention2
Acquisition of at least one histological sample
Time frame
during the intervention3
histopathological classification of the pulmonary lesion
Time frame
From enrollment to the end of treatment at 8 days.Secondary outcomes
1
Procedure duration
Time frame
during the intervention2
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.3
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 months4
cost analysis
Total billed costs in CHF for the bronchoscopy excl. anesthesia
Time frame
From enrollment to the end of treatment at 8 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov