Clinical trial NCT06310577: Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy
Official title: Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Disease
Keywords: Bronchoscope adapter
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"
timeFrame: During the bronchoscopy procedure
measure: Heart rate (bpm)
timeFrame: Immediately before the procedure and during the procedure
measure: Blood pressure (mmHg)
timeFrame: Immediately before the procedure and during the procedure
measure: Oxygenation as measured by SpO2
timeFrame: Immediately before the procedure and during the procedure
measure: Assessment of adverse events
timeFrame: During the procedure and immediately after the procedure
Secondary outcomes:
measure: Evaluation of bronchoscope adapter tidal volume loss efficacy
timeFrame: During the bronchoscopy procedure
measure: Evaluation of bronchoscope adapter aerosolization efficacy
timeFrame: During the bronchoscopy procedure
measure: Peak airway pressure (cmH2O)
timeFrame: During the bronchoscopy procedure
measure: Dynamic compliance (mL/CmH2O)
timeFrame: During the bronchoscopy procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Katherine Su, MD
role: PRINCIPAL_INVESTIGATOR
References: