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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310577
• Other study ID #: EH23-343
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: NorthShore University HealthSystem
• Contact: Principal Investigator
• Phone: (847) 570-2868
• Email: KSu[@]northshore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Device:
• Leak-free bronchoscope adapter
Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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