General anesthesia versus conscious sedation for radial endobronchial ultrasound
A Randomized Controlled Trial of gEneral aneStheSia vs consciOUs Sedation in Radial endobronChial Ultrasound for Peripheral Pulmonary lEsions
NA · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT06950515
This trial will see if general anesthesia or conscious sedation gives better diagnostic results for adults undergoing radial endobronchial ultrasound to sample peripheral lung nodules.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval (other) |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06950515 on ClinicalTrials.gov |
What this trial studies
This is a randomized, multicenter trial comparing diagnostic yield of peripheral radial endobronchial ultrasound (pEBUS) performed under general anesthesia versus conscious sedation. Adults with peripheral lung lesions deemed accessible by experienced interventional pulmonologists are randomized to one of the two sedation strategies and undergo pEBUS with standard sampling techniques. Patient comfort questionnaires are collected before discharge and final pathology and procedure outcomes are reviewed from the medical record about one month after the procedure. Key exclusions include planned use of electromagnetic navigation/robotic bronchoscopy, suspicious mediastinal lymph nodes requiring EBUS-TBNA, or contraindications to bronchoscopy.
Who should consider this trial
Good fit: Adults (≥18) with a peripheral lung lesion under 5 cm that an interventional pulmonologist judges accessible by pEBUS and who agree to have pEBUS as their diagnostic procedure are ideal candidates.
Not a fit: Patients who need electromagnetic navigation, augmented fluoroscopy, robotic bronchoscopy, have suspicious lymph nodes requiring separate EBUS-TBNA, or have contraindications to bronchoscopy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify the sedation approach that yields more accurate diagnoses and improves patient comfort during pEBUS.
How similar studies have performed: Previous comparisons of sedation strategies for pEBUS are limited and have not shown a clear, consistent advantage for general anesthesia, so direct evidence is inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and ability to consent * Peripheral lung lesion less than 5cm in average diameter on axial CT images (A lung lesion will be considered peripheral if it is located beyond the origin of the subsegmental bronchi and presumed not to be visible endoscopically in white light during the evaluation of the CT scan by an interventional pulmonologist.) * Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist * Decision by the medical team and the patient to use pEBUS as a diagnostic modality for the lung lesion Exclusion Criteria: * Planned use of electromagnetic navigation, augmented fluoroscopy or robotic bronchoscopy in addition to pEBUS. The use of virtual bronchoscopy planning is permitted * Presence of suspicious lymph nodes (size ≥ 10mm and/or moderate or greater hypermetabolism) on imaging which are accessible by l-EBUS and for which rapid on-site cytological analysis will be used * Contraindication to bronchoscopy or biopsies such as an unstable medical condition or uncorrected coagulopathy * Current pregnancy * Lack of free and informed consent
Where this trial is running
Québec, Quebec
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Marc Fortin, MD
- Email: marc.fortin@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancers, Peripheral Pulmonary Nodules, Lung cancer, Peripheral pulmonary nodules, bronchoscopy, peripheral endobronchial ultrasound, sedation