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

NCT ID: NCT06310577

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Bronchoscopy is a commonly performed procedure where a camera tipped device is used to look into a patient's lung. To perform bronchoscopy, a "standard commercial adapter" is connected to the ventilator tubing, which lets the doctors use the bronchoscope.The design of the "standard commercial adapter" can cause about 20% of air to escape from the ventilator to the OR. This leaked air causes two issues: first, this can lead to lower oxygen levels and can limit the amount of time your physician can perform bronchoscopy. Second, the leaked air can lead to the spread of harmful particles like anesthesia gas to the OR. These particles can harm the staff in the operating room or spread to other patients in the hospital.

This study will compare the benefit of the "standard commercial adapter" to the newly developed "leak-free adapter". The investigational procedure being studied here is repeating the bronchoscopy with the leak-free adapter. Outcomes (which measure the benefit of the new adapter) will be measured for each adapter independently. Bronchoscopy using both devices will be performed by the physician performing the procedure.

Conditions

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Pulmonary Disease

Keywords

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Bronchoscope adapter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Self-controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Leak free bronchoscope adapter

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.

Group Type EXPERIMENTAL

Leak-free bronchoscope adapter

Intervention Type DEVICE

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

Interventions

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Leak-free bronchoscope adapter

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Significant protocol deviation
2. Significant non-compliance with protocol or study requirements
3. An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
4. Consent is withdrawn.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Katherine Su

Clinical Assistant Professor, Attending Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Su, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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EH23-343

Identifier Type: -

Identifier Source: org_study_id