Study of Procedural Efficiency in EBUS With Dual Versus Single NEEDLEs: Evaluating the Value of a Second Needle in EBUS as it Pertains to Economic and Environmental Impact (SPEED NEEDLE)

Are Two Needles Really Better Than One? A Time, Economic, and Environmental Evaluation of EBUS-TBNA

Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the economic and environmental impact and time involved in using one versus two needles.

Study Overview

• Status: Active, not recruiting
• Conditions: Mediastinal and Hilar Lymphadenopathy
• Intervention / Treatment: Diagnostic test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

Detailed Description

Endobronchial Ultrasound (EBUS) is a mainstay of diagnostic bronchoscopy, as it is performed for mediastinal and hilar lymph node sampling for cancer staging, diagnosis of sarcoidosis, lymphoma, infection, and other disease processes. It is a procedure that is commonplace in all bronchoscopy suites across the world.

In our bronchoscopy suite, our current practice varies based on the bronchoscopist and number of lymph nodes requiring sampling in a procedure (can range from 1-5) as to whether one or two needles are utilized. The bronchoscopist may use two needles to save time when multiple lymph nodes must be biopsied or if an individual node needs to be biopsied several times to obtain more tissue for pathologic study.

EBUS needles are single use and there is one randomized trial (n=20 patients) that showed a decreased time of procedure in patients where two needles were used versus one (Khan et al., 2013). However, no data exist evaluating the economic impact (cost of needle versus endoscopy dollars saved) or environmental impact of using one versus two needles. This study will examine these factors to determine the optimal way to perform this procedure in the future, considering the procedure and anesthesia time, economic costs, and environmental costs.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing a bronchoscopy with lymph node sampling

Exclusion Criteria:

• Unable to get a bronchoscopy procedure for various reasons
• Other criteria per protocol uploaded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One EBUS Needle; Patients underwent a standard of care EBUS with one needle utilized in the procedure.	Diagnostic test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.; We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.
Experimental: Two EBUS Needle; Patients underwent standard of care EBUS with two needles used.	Diagnostic test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.; We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time Under Anesthesia	During bronchoscopy procedure

Collaborators and Investigators

• Sponsor: Christopher Kapp
• Collaborators: Duke University; University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 15, 2025
• First Submitted That Met QC Criteria: October 15, 2025
• First Posted (Actual): October 20, 2025

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Bronchoscopy; EBUS
• Other Study ID Numbers: STU00220729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes