General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound

NANot yet recruitingINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2029

Conditions
Lung CancersPeripheral Pulmonary Nodules
Interventions
PROCEDURE

Peripheral EBUS under Concious sedation

In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RAS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study

PROCEDURE

Peripheral EBUS under General Anesthesia

In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RAS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RAS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol

Trial Locations (1)

G1V 4G5

Institut universitaire de cardiologie et de pneumologie de Québec, Québec

All Listed Sponsors
lead

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER