Increasing Duration of Apnea Without Desaturation at Induction of Anesthesia in Morbidly Obese Patients Using "Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of safe apnea
研究概览
简要总结
This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.
详细描述
Background Providing safe anesthesia for surgery in obese patients requires specific consideration of the pathophysiological changes and respiratory complications are frequent. Anesthesia induction needs special attention in this patient population. A decrease in functional residual capacity (FRC) after induction of anesthesia dramatically shortens the duration of apnea without desaturation (DAWD) during which the airway can be secured.
Several measures such as positioning in a semi sitting position, preoxygenation with PEEP and passive insufflation of oxygen during laryngoscopy have been shown to prolong the DAWD. None of these measures is able to produce positive endexpiratory pressure (PEEP) during laryngoscopy which would counteract the loss of FRC and therefore prolong the DAWD further.
Transnasal humidified rapid insufflation ventilator exchange (THRIVE, also knowns as "high flow nasal oxygen therapy" and "heated and humidified nasal oxygen") devices have been used for several years in intensive care and are available from numerous vendors. With THRIVE, heated and humidified oxygen is insufflated via nasal prongs at a rate up to 120 l/minute and it has been shown that this creates levels of PEEP, proportional to the amount of gas flow. Using THRIVE during the apneic phase of anesthesia induction in obese patients might be superior compared to low flow oxygen techniques as THRIVE generates PEEP during laryngoscopy, which might counteract the loss of FRC and consequently might prolong the DAWD.
Aim of the project This project will investigate the DAWD when using THRIVE vs. low flow nasal oxygen at anesthesia induction in obese patients.
Hypothesis The duration of apnea without desaturation is longer in the "THRIVE" group compared to the "low flow oxygen" group.
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
- Single (Investigator)
盲法说明
The monitor measuring the main outcome parameter will be in a separate room
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •American Society of Anesthesiologists physical status classification class 2-3
- •BMI > 40
- •elective surgery under general anesthesia
排除标准
- •expected difficult airway (El Ganzouri Risk Index > 6)
- •oxygen saturation of less than 98% despite adequate preoxygenation,
- •nasal obstruction
- •smoker, more than 10 cigarettes per day
- •chronic respiratory disease
- •FEV1 (forced expiratory volume in one second) < 70%
- •elevated intracranial pressure
- •unable to give informed consent
- •Pregnant or breast feeding
研究组 & 干预措施
Low flow Oxygen Group
low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs
干预措施: low flow passive oxygenation (Procedure)
THRIVE Group
high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system
干预措施: high flow passive oxygenation (Procedure)
结局指标
主要结局
Duration of safe apnea
时间窗: duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.
The duration until oxygen saturation drops to 95% during laryngoscopy
次要结局
- blood gas analysis(every 2 minutes after rocuronium was given until 2 minutes after intubation)
研究者
Thomas Hamp
Principal Investigator
Medical University of Vienna