General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound

NCT06950515 | Recruiting

• 1 other identifier: 2025-4122
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancers; Peripheral Pulmonary Nodules

Keywords

Lung cancer; Peripheral pulmonary nodules; bronchoscopy; peripheral endobronchial ultrasound; sedation

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of pEBUS under general anesthesia and conscious sedation

  The diagnostic yield of pEBUS according to a strict definition, a procedure being defined as diagnostic if it allows a specific benign or malignant diagnosis using the samples obtained. Non-specific findings not allowing a precise diagnosis and accompanied by a follow-up evolution consistent with the findings (e.g.: non-specific inflammation followed by spontaneous resolution of the lesion) will not be considered diagnostic. Cryobiopies will be excluded from the primary outcome as they cannot be safely performed under conscious sedation. We do not primarly aim to evaluate the added value of cryobiopsy but to compare two modalities of sedation. The comparison between the diagnostic yields for the two types of sedation will be made with a χ2 test, if the distribution of the data is normal

  At recruitment completion (expected time 2 years)

Secondary Outcomes (8)

• Diagnostic yield of pEBUS

  At recruitment completion (expected time 2 years)

• Diagnostic yield of pEBUS

  At recruitment completion (expected time 2 years)

• Diagnostic yield of pEBUS

  At recruitment completion (expected time 2 years)

• Duration of the procedure

  Assessment will begin with the start of the procedure (bronchoscope insertion) and end at procedure completion (bronchoscope removal)

• Duration of the procedure

  Assessment will begin when the participant enters the procedure room and end when he leaves it. Result will be recorded when the patient leaves the procedure room.

Study Arms (2)

Conscious sedation arm

EXPERIMENTAL

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 Concious sedation

General anesthesia arm

EXPERIMENTAL

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

Procedure: Peripheral EBUS under General Anesthesia

Interventions

Peripheral EBUS under Concious sedation PROCEDURE

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

Conscious sedation arm

Peripheral EBUS under General Anesthesia PROCEDURE

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

General anesthesia arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marc Fortin, MD

CONTACT

418-656-8711; marc.fortin@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pathologist will be blinded when reviewing biopsy specimens.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a multicenter randomized clinical trial to compare the diagnostic yield of pEBUS under general anesthesia and conscious sedation in the context of the investigation of peripheral pulmonary lesions.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 30, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)