Pulmonary Disease
Conditions
Keywords
Bronchoscope adapter
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.
Interventions
Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Self-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Consent is withdrawn.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed