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

Endeavor Health

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Pulmonary Disease

Interventions

Leak-free bronchoscope adapterDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Consent is withdrawn.

Locations (1)

NorthShore University HealthSystem

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: During the procedure and immediately after the procedure

Secondary Outcomes

Evaluation of bronchoscope adapter tidal volume loss efficacy

Data from ClinicalTrials.gov

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