Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol

Not Applicable

Not yet recruiting

• Conditions: Lung Lesions; Robotic Assisted Bronchoscopy; Propofol; Bronchoscopy; Bronchoscopy Biopsy

• Registration Number: NCT07006311
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study Start: 2025-06-01
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
histopathological classification of the pulmonary lesion	From enrollment to the end of treatment at 8 days.
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

Secondary Outcome Measures

Name	Time	Method
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.