Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy

NCT06310577 | Withdrawn FDA Device

• 1 other identifier: EH23-343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.

Conditions

Pulmonary Disease

Keywords

Bronchoscope adapter

Outcome Measures

Primary Outcomes (5)

• Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"

  Assessment of the capacity to complete the full bronchoscopic procedure using the "leak-free adapter" device.

  During the bronchoscopy procedure

• Heart rate (bpm)

  Prior to the initiation of the bronchoscopic procedure, the patient's will heart rate will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.

  Immediately before the procedure and during the procedure

• Blood pressure (mmHg)

  Prior to the initiation of the bronchoscopic procedure, the patient's blood pressure will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.

  Immediately before the procedure and during the procedure

• Oxygenation as measured by SpO2

  Quantification and comparison of patient oxygenation using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter". A pulse oximeter will be used to measure the patient's oxygen saturation (SpO2). Prior to bronchoscopy, the patients circulating oxygen saturation will be recorded during 10 ventilated breaths. Upon initiation of bronchoscopy, the SpO2 level will be measured throughout the procedure.

  Immediately before the procedure and during the procedure

• Assessment of adverse events

  Any adverse events related to the leak-free adapter use will be evaluated.

  During the procedure and immediately after the procedure

Secondary Outcomes (4)

• Evaluation of bronchoscope adapter tidal volume loss efficacy

  During the bronchoscopy procedure

• Evaluation of bronchoscope adapter aerosolization efficacy

  During the bronchoscopy procedure

• Peak airway pressure (cmH2O)

  During the bronchoscopy procedure

• Dynamic compliance (mL/CmH2O)

  During the bronchoscopy procedure

Study Arms (1)

Leak free bronchoscope adapter

EXPERIMENTAL

As a standard part of procedure, bronchoscopy will be performed using the "standard commercial adapter". Following the standard bronchoscope adapter use, leak-free bronchoscope adapter will be tested to compare the amount, and quality of air leaked between the"standard commercial adapter" and the "leak-free adapter.

Device: Leak-free bronchoscope adapter

Interventions

Leak-free bronchoscope adapter DEVICE

Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.

Leak free bronchoscope adapter

Eligibility Criteria

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

You may qualify if:

• Participants who will be undergoing elective intubation for either a surgical or bronchoscopic procedure (diagnostic or therapeutic)
• Both males and females
• Adults 18 years and older

You may not qualify if:

• Significant protocol deviation
• Significant non-compliance with protocol or study requirements
• An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
• Consent is withdrawn.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Chicago, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Katherine Su, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Attending Surgeon

Model Details: Self-controlled

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 15, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)