Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient: A Randomized, Double-Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Apneic Time
研究概览
简要总结
This prospective, randomized, double-blind study is intended to enroll a total of 100 patients with a BMI ≥ 40 kg/m2 and another 100 patients with a BMI ≥ 30 kg/m2 (but less than 40 kg/m2) undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either 15 L/min O2 or 15 L/min air from a standard nasal cannula during a simulated prolonged laryngoscopy. The anesthesia provider will do a direct laryngoscopy to ensure that the patient has a Cormack-Lehane grade I-II airway. Patients who have grade III-IV airways will be excluded from further study procedures and not analyzed. The rest of the anesthetic will not deviate from the standard of care. Anesthesia providers will be blinded as to whether patients are receiving oxygen or air during the apneic period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •18-80 years old
- •Obesity (BMI ≥ 30 kg/m2 ≤ 40 kg/m2)
- •Morbid obesity (BMI ≥ 40 kg/m2)
- •Scheduled for a non-emergent operation that requires general endotracheal anesthesia
- •Willing and able to consent in English or Spanish
- •No current history of advanced pulmonary or cardiovascular disease
排除标准
- •Age less than 18 or older than 70
- •BMI < 30 kg/m2
- •Patient does not speak English or Spanish
- •Family or personal history of malignant hyperthermia
- •Patient refusal
- •Monitored anesthesia care (MAC) or regional anesthesia planned
- •Pregnant or nursing women
- •"Stat" (emergent) cases
- •Moderate to severe pulmonary disease (e.g., asthma, COPD, pulmonary fibrosis, pulmonary hypertension)
- •Respiratory infection within the past 14 days (e.g., pneumonia, bronchitis)
- •SpO2 < 97% on room air
- •Moderate to severe cardiac disease (e.g., CHF, CAD, aortic stenosis)
- •Severe gastroesophageal reflux disease (GERD)
- •Nasal obstruction (e.g., tumor)
- •Elevated intracranial pressure (e.g., brain tumor)
- •History of difficult airway
结局指标
主要结局
Apneic Time
时间窗: Intraoperative
To determine whether apneic oxygenation via nasal cannula oxygen results in a longer period of apnea (SpO2 ≥ 95%) during a simulated prolonged laryngoscopy in obese and morbidly obese patients.
次要结局
- Resaturation Time(Intraoperative)
研究者
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center