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

Endeavor Health

Status: Withdrawn

Conditions: Pulmonary Disease

Treatments: Device: Leak-free bronchoscope adapter

Study type: Interventional

Funder types: Other

Identifiers

NCT06310577

EH23-343

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Consent is withdrawn.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Leak free bronchoscope adapter

Experimental group

Description:

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.

Treatment:

Device: Leak-free bronchoscope adapter