Anesthesia vs Sedation for Lung Lesions

(RESSOURCE Trial)

Overseen By Marc Fortin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Pregnancy, Unstable condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for performing an endoscopic procedure called pEBUS (Peripheral Endobronchial Ultrasound) to examine lung lesions. It compares the effectiveness of general anesthesia versus conscious sedation in achieving better diagnostic results. The trial focuses on patients with lung lesions smaller than 5 cm that are not visible with regular light during a scan. Patients who have already chosen pEBUS with their doctor for their lung lesion may be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to medical knowledge and potentially enhance diagnostic methods for lung lesions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these anesthesia and sedation methods are safe for endoscopic investigation of lung lesions?

Research has shown that both conscious sedation and general anesthesia are generally safe for endoscopic procedures like peripheral EBUS, a technique to examine the lungs.

Studies have found that conscious sedation for peripheral EBUS is safe, with few complications, and patients generally tolerate it well. One study reported that radial-probe EBUS, a specific type of endoscopic ultrasound, had a low rate of complications, making it a reliable option for diagnosing lung issues.

Research also supports the safety of general anesthesia during peripheral EBUS. Studies report low rates of minor complications, such as slight bleeding and low oxygen levels, which usually don't require further medical attention. Another study confirmed that this approach is both effective and low-risk.

In summary, studies indicate that both conscious sedation and general anesthesia for peripheral EBUS are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether conscious sedation or general anesthesia is better for performing Peripheral EBUS (Endobronchial Ultrasound) on lung lesions. Conscious sedation allows patients to breathe on their own and be more aware during the procedure, potentially reducing recovery time and the risks associated with deep anesthesia. On the other hand, general anesthesia ensures the patient is completely unconscious, which might lead to more precise control during the procedure. By comparing these two approaches, the trial aims to find out which method offers the best balance of effectiveness and safety for patients with lung lesions.

What evidence suggests that this trial's treatments could be effective for investigating lung lesions?

This trial will compare two methods of performing peripheral endobronchial ultrasound (EBUS) for diagnosing lung problems: one under conscious sedation and the other under general anesthesia. Studies have shown that EBUS with the patient awake but relaxed (conscious sedation) can achieve success rates as high as 88% in some cases. Meanwhile, research indicates that EBUS while the patient is fully asleep (general anesthesia) can achieve similar success rates, around 87% to 88%, especially in certain patient groups. Both methods are considered safe and effective, with studies suggesting they are equally good at diagnosing lung issues. The choice between being awake or asleep during the procedure often depends on patient comfort and available resources, as both methods have shown promising results in diagnosing lung conditions. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with lung lesions, potentially due to cancer. Participants should be suitable for a procedure called peripheral endobronchial ultrasound (pEBUS), which can be done under either conscious sedation or general anesthesia.

Inclusion Criteria

My lung lesion is smaller than 5cm on a CT scan.

Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist

My doctor and I have agreed to use pEBUS for diagnosing my lung issue.

Exclusion Criteria

Current pregnancy

Lack of free and informed consent

I have large or highly active lymph nodes that can be checked with a special scope.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person, phone, or telemedicine)

Randomization and Procedure

Participants are randomized to either general anesthesia or conscious sedation and undergo the pEBUS procedure

1 day

1 visit (in-person)

Immediate Post-Procedure Recovery

Participants recover from the procedure and complete comfort questionnaires before discharge

Same day as procedure

1 visit (in-person)

Follow-up

Participants' medical records are reviewed for results and late complications; follow-up continues at 1 and 2 years if the procedure is not diagnostic

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral EBUS under Conscious Sedation
• Peripheral EBUS under General Anesthesia

Trial Overview The study aims to compare the effectiveness of pEBUS when performed under two different conditions: conscious sedation and general anesthesia. The goal is to determine which method provides better diagnostic results and patient comfort.

How Is the Trial Designed?

Group I: General anesthesia arm Experimental Treatment 1 Intervention

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

Group II: Conscious sedation arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

26

Recruited

6,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5063440/

Radial-probe EBUS for the diagnosis of peripheral pulmonary ... Studies have shown that radial-probe EBUS improves diagnostic rates for peripheral pulmonary nodules, particularly for lesions smaller than 2 cm in diameter.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949789224000035

The Diagnostic Yield of Cone Beam CT Combined With ... There are limited data for the combination of r-EBUS and ENB; however, a few studies have reported a diagnostic yield up to 88%. Virtual bronchoscopy/virtual ...

3. tlcr.amegroups.org tlcr.amegroups.org/article/view/100771/html

guided transbronchial needle aspiration (TBNA) enhances ... A 2010 meta-analysis by Steinfort et al. reported that the diagnostic yield of rEBUS-guided TBLB was 56.3% for lung lesions ≤2 cm and 77.7% for ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1759-7714.15376

Optimal approach for diagnosing peripheral lung nodules ... This study had a diagnostic yield of 63.5%, which is very meaningful considering that all procedures were performed under moderate conscious ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107026/

Diagnostic yield and safety of biopsy guided by ... Several studies investigating ENB's efficacy in diagnosing peripheral pulmonary nodules have reported variable diagnostic yields ranging from 69%–82.5%. · Second ...

6. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-019-1149-0

Clinical outcomes of radial probe endobronchial ultrasound ... EBUS-GS was shown to be a safe procedure with an acceptable diagnostic yield, even when performed in patients with pulmonary emphysema. The ...

7. thorax.bmj.com thorax.bmj.com/content/79/Suppl_2/A227.1

P198 Radial EBUS with electromagnetic navigation ... Conclusions ENB is a safe and effective tool for the diagnosis of peripheral pulmonary lesions and can be performed in a standard bronchoscopy suite using ...

8. tlcr.amegroups.org tlcr.amegroups.org/article/view/77131/html

Diagnostic accuracy and safety of electromagnetic navigation ... Conclusions: EMN-TTNB under moderate sedation showed an acceptable diagnostic accuracy and good safety profile. The new technology allows ...