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

Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease
• Intervention / Treatment: Device: Leak-free bronchoscope adapter

Detailed Description

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
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: (847) 570-2868; Email: KSu@northshore.org

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Leak-free bronchoscope adapter; Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of bronchoscope adapter tidal volume loss efficacy	Quantification and comparison of the proportion of tidal volume delivered to a patient by the ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".	During the bronchoscopy procedure
Evaluation of bronchoscope adapter aerosolization efficacy	Quantification and comparison of aerosolized gas delivered to the ambient environment by the ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".	During the bronchoscopy procedure
Peak airway pressure (cmH2O)	Quantification and comparison of pulmonary pressure parameters by the ventilator during bronchoscopy. Peak airway pressure (cmH2O) will be obtained from ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".	During the bronchoscopy procedure
Dynamic compliance (mL/CmH2O)	Quantification and comparison of pulmonary pressure parameters by the ventilator during bronchoscopy. Dynamic compliance (mL/CmH2O) will be obtained from ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".	During the bronchoscopy procedure

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Katherine Su, MD, NorthShore University Healthsystem

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscope adapter
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: EH23-343

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No