The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Tracheal Bronchoscope Placements Required
研究概览
简要总结
The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for diagnostic bronchoscopy
排除标准
- •Patients with significantly decreased myocardial function (ejection fraction < 50%)
- •Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
- •Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
- •Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
- •Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m
- •Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
- •Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
- •Patients with skull base defects.
- •Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
- •Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 < 95%.
- •Obese patients with BMI above 35 kg/m
- •Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
- •Patients with hiatal hernia and full stomach patients.
- •Patients on immunosuppressive medications.
- •Patient's refusal to participate in the study.
- •Patients who do not understand English or mentally handicapped.
- •Pregnant or breastfeeding patients.
结局指标
主要结局
Number of Tracheal Bronchoscope Placements Required
时间窗: Duration of surgery (average approximately 1 hour)
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
时间窗: Duration of surgery (average approximately 1 hour)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Time to Bronchoscope Placement in Trachea
时间窗: Duration of surgery (average approximately 1 hour)
Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.
Duration of Procedure
时间窗: Duration of surgery (average approximately 1 hour)
Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.
Awakening/Extubation Time
时间窗: Duration of surgery (average approximately 1 hour)
Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
次要结局
- Recovery Room Discharge-ready Time(Duration of recovery room stay (average approximately 1 hour))
- Time to Patient Being Alert and Oriented x 4(Duration of surgery (average approximately 1 hour))
- First Pain Score in Recovery Room(Duration of recovery room stay (average approximately 1 hour))
- Discharge-ready Pain Score(Day of discharge (up to 2 minutes))
- Analgesic Consumption(Recovery room to 7th postoperative day)
研究者
Vladimir Nekhendzy
Clinical Professor of Anesthesiology and Otolaryngology
Stanford University