Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Heart rate (bpm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who will be undergoing elective intubation for either a surgical or bronchoscopic procedure (diagnostic or therapeutic)
- •Both males and females
- •Adults 18 years and older
排除标准
- •Significant protocol deviation
- •Significant non-compliance with protocol or study requirements
- •An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
- •Consent is withdrawn.
结局指标
主要结局
Heart rate (bpm)
时间窗: 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.
Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"
时间窗: During the bronchoscopy procedure
Assessment of the capacity to complete the full bronchoscopic procedure using the "leak-free adapter" device.
Oxygenation as measured by SpO2
时间窗: 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.
Assessment of adverse events
时间窗: During the procedure and immediately after the procedure
Any adverse events related to the leak-free adapter use will be evaluated.
Blood pressure (mmHg)
时间窗: 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.
次要结局
- Evaluation of bronchoscope adapter aerosolization efficacy(During the bronchoscopy procedure)
- Dynamic compliance (mL/CmH2O)(During the bronchoscopy procedure)
- Evaluation of bronchoscope adapter tidal volume loss efficacy(During the bronchoscopy procedure)
- Peak airway pressure (cmH2O)(During the bronchoscopy procedure)
研究者
Katherine Su
Clinical Assistant Professor, Attending Surgeon
Endeavor Health