Apnoeic Oxygenation in Obstructive Sleep Apnea: a Randomised Controlled Trial Comparing Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) Combined With Nasopharyngeal Airway and THRIVE Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 95%. Comparing oxygenation with THRIVE combined with nasopharyngeal or THRIVE technique.
研究概览
简要总结
The purpose of the study is to compare effectiveness of different methods of achieving oxygenation in obstructive sleep apnea patients. The investigators intend to compare transnasal humidified rapid-insufflation ventilator exchange (THRIVE) combined with nasopharyngeal airway with THRIVE alone.
详细描述
With the increasing prevalence of obesity, the prevalence of OSA is also rising, ranging from 9% to 25% in the general adult population. Patients with OSA have features of an anatomically tricky airway due to a crowded collapsible pharyngeal space, compounded by physiological problems related to lower functional residual capacity and increased oxygen consumption, leading to faster oxygen desaturation. Meanwhile, patients with OSA, compared to patients without OSA, have a 3-4 times higher risk of difficult intubation, difficult mask ventilation, or both. Apnoea time is a potentially hazardous period during induction of anesthesia and it is particularly so in patients with OSA. OSA patients undergoing general anesthesia gave rise to many concerns and challenges, and strategies to extend the apneic time were required. Identifying the most effective method of oxygenating OSA patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 and 75 years requiring general anesthesia
- •American society of Anesthesiologists (ASA) physical status classification system: I - III
- •diagnosed as OSA.
排除标准
- •Patients with chronic respiratory disease, uncontrolled hypertension, ischemic heart disease, congestive heart failure, increased intracranial pressure, gastroesophageal reflux disease,
- •patients' arterial hemoglobin saturation < 98% after preoxygenation,
- •patients were nasal obstruction
- •patients with previous or anticipated difficult facemask ventilation or intubation,
- •patients with known allergy or contraindication to propofol, remifentanil, rocuronium, or midazolam.
- •patients who were unable to give informed consent
结局指标
主要结局
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 95%. Comparing oxygenation with THRIVE combined with nasopharyngeal or THRIVE technique.
时间窗: duration from apnea to eighteen (18) minutes
oxygenation is delivered either by THRIVE combined with nasopharyngeal or the THRIVE technique alone. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 95% is recorded. When this occurs the trial is stopped and the patient is intubated.If 18 minutes is reached before SpO2 = 95% then the trial is stopped.
次要结局
- Arterial partial pressure of oxygen (PaO2)(at the time apnea start, five/ten minutes after apnea and at the end of apnea)
- Arterial carbon dioxide pressure (PaCO2)(at the time apnea start, five/ten minutes after apnea and at the end of apnea)
- Concentration of arterial blood lactate(at the time apnea start, five/ten minutes after apnea and at the end of apnea)
- Arterial blood pH(at the time apnea start, five/ten minutes after apnea and at the end of apnea)
- mininmum SPO2(from apnea start to 1minute after intubation)
- desaturation duration(SPO2 100-99%,-98%,-95%)(from apnea start to 1minute after intubation)
- Transcutaneous CO2 (tc CO2 increase rate(duration from apnea start to 18 minutes)
- End-tidal carbon dioxide (ETCO2) increase rate(duration from apnea start to 18 minutes)
- highest ETCO2 value ( after intubation the first PetCO2 and the highest PETCO2 among the first five)(duration from apnea start to 20 minutes)