The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical 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
- Duration of Surgery (Primary Surgical Outcome)
研究概览
简要总结
The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).
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 short, non-laser laryngologic surgery
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.
- •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
Duration of Surgery (Primary Surgical Outcome)
时间窗: intraoperative (up to one hour)
Suspension Time (Primary Surgical Outcome)
时间窗: intraoperative (up to 5 min)
Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
时间窗: intraoperative (up to 5 min)
Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
时间窗: intraoperative (up to 20 min)
time from end of surgery to responding to commands/extubation
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
时间窗: intraoperative (up to one hour)
次要结局
- Opioid Consumption(Recovery room admission and discharge (up to 2 hours))
- Change in Voice Handicap Index (VHI)(Preoperative assessment and one month after surgery)
- Alertness(Recovery room admission (up to 30 min following admission to recovery room))
- Quality of Recovery(One week after surgery)
- Numerical Pain Rating Scores(Recovery room admission and discharge (up to 2 hours))
- Recovery Room Time(Up to 2 hours after procedure)
研究者
Vladimir Nekhendzy
Clinical Professor of Anesthesiology and Otolaryngology
Stanford University