General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Peripheral EBUS under Concious sedation
  • Peripheral EBUS under General Anesthesia

Treatment groups

306 Participants
are divided into 2 treatment groups