The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery
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
- Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
研究概览
简要总结
The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation 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 cannula: 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 laser laryngeal 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 oxygen saturation (SpO2) < 95% .
- •Obese patients with BMI > 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
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.
Mean Arterial Pressure (MAP)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Systemic Vascular Resistance Index (SVRI)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne\*seconds per centimetre\^5 (dyne\*sec/cm\^5).
Number of Suspension Adjustments
时间窗: Duration of surgery (average approximately 1 hour)
Number of adjustments of the suspension laryngoscope.
pH in Blood
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.
Stroke Volume Index (SVI)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m\^2).
Cardiac Index (CI)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Time to Suspension
时间窗: Duration of surgery (average approximately 1 hour)
Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
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.
Heart Rate
时间窗: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Duration of Surgery
时间窗: Duration of surgery (average approximately 1 hour)
Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.
次要结局
- Total Remifentanil Dose (Anesthetic)(Duration of surgery (average approximately 1 hour))
- Recovery Room Discharge-ready Time(Duration of recovery room stay (average approximately 1 hour))
- Pain Score at Discharge From Recovery Room(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))
- Time to Spontaneous Ventilation(Duration of surgery (average approximately 1 hour))
- Analgesic Consumption(Recovery room to 7th postoperative day)
- Count of Participants Requiring Jet Ventilation(Duration of surgery (average approximately 1 hour))
- Apnea Time(Duration of surgery (average approximately 1 hour))
- Total Propofol Dose (Anesthetic)(Duration of surgery (average approximately 1 hour))
- Total Ephedrine Dose (Vasoactive Drug)(Duration of surgery (average approximately 1 hour))
- Duration of Anesthesia(Duration of surgery (average approximately 1 hour))
- Total Phenylephrine Dose (Vasoactive Drug)(Duration of surgery (average approximately 1 hour))
- Total Labetalol Dose (Vasoactive Drug)(Duration of surgery (average approximately 1 hour))
- First Pain Score in Recovery Room(Duration of recovery room stay (average approximately 1 hour))
- Quality of Recovery (QoR)15 Score(Prior to procedure, and 1-2 hours after procedure)
研究者
Vladimir Nekhendzy
Clinical Professor of Anesthesiology and Otolaryngology
Stanford University