NCT06310577

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Leak-free bronchoscope adapter	Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.

Timeline

• Start date: 2024-01-17
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-03-15
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study