Not provided
Not provided
Not provided
Not provided
Not provided
No participants enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leak free bronchoscope adapter | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leak-free bronchoscope adapter | Device | Bronchoscopy using both a standard adapter and a leak-free adapter will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluation of bronchoscope adapter aerosolization efficacy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katherine Su, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Chicago | Illinois | 60201 | United States |
Not provided
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Self-controlled
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |