Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Benefit of Nasal PAP Versus Nasal Administration of Oxygen
研究概览
简要总结
Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.
详细描述
124 patients with BMI> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist & patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or older
- •Patients undergoing upper endoscopic ultrasound
- •American Society of Anesthesiology (ASA) Physical Status I-III
- •BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
- •Has provided written informed consent
排除标准
- •Inpatient status
- •Active Congestive Heart Failure Exacerbation
- •Untreated ischemic heart disease
- •Acute exacerbation of respiratory disorders, including COPD and asthma
- •Emergent procedures
- •Previous enrollment in this study
- •Inability to provide informed consent
- •Additional medical testing planned for the same day
- •History of allergic reaction to Propofol
- •Tracheostomy
- •Supra-glottic or sub-glottic tumor
- •Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
结局指标
主要结局
Benefit of Nasal PAP Versus Nasal Administration of Oxygen
时间窗: 60 minutes.
Compare the incidence, duration, and severity of oxygen desaturation
次要结局
- Procedural Interruptions(60 minutes)
- Total Amount of Propofol for Adequate Sedation(60 minutes.)
- Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS)(120 minutes)
研究者
John DeWitt
Associate Professor of Medicine
Indiana University