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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Disease
• Interventions: Device: Leak-free bronchoscope adapter

• Registration Number: NCT06310577
• Lead Sponsor: Endeavor Health

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.

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 Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-15
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Start: 2025-03
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leak free bronchoscope adapter	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.

Primary Outcome Measures

Name	Time	Method
Heart rate (bpm)	Immediately before the procedure and during the procedure	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.
Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"	During the bronchoscopy procedure	Assessment of the capacity to complete the full bronchoscopic procedure using the "leak-free adapter" device.
Oxygenation as measured by SpO2	Immediately before the procedure and during the procedure	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.
Assessment of adverse events	During the procedure and immediately after the procedure	Any adverse events related to the leak-free adapter use will be evaluated.
Blood pressure (mmHg)	Immediately before the procedure and during the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of bronchoscope adapter aerosolization efficacy	During the bronchoscopy procedure	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".
Dynamic compliance (mL/CmH2O)	During the bronchoscopy procedure	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".
Evaluation of bronchoscope adapter tidal volume loss efficacy	During the bronchoscopy procedure	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".
Peak airway pressure (cmH2O)	During the bronchoscopy procedure	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".

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Chicago, Illinois, United States