SuperNO2VA™ and General Anesthesia Postoperative Care: Comparing the Incidence, Severity, and Duration of Postoperative Oxygen Desaturation Between SuperNO2VA™ and Standard of Care, a RCT
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Hypoxemia
研究概览
简要总结
The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively in PACU)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 scheduled for general anesthesia with a supraglottic device or ETT
- •American Society of Anesthesiology (ASA) Physical Status I-IV (E)
- •Has provided written informed consent
- •BMI > 35 kg/m2 or documented Obstructive Sleep Apnea
排除标准
- •Inability to give informed consent
- •Allergy to Propofol
- •Any condition, in the Investigator's opinion, that would conflict or otherwise prevent the subject from complying with study required procedures, schedule or other study conduct
- •BMI < 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea
- •Known diagnosis of moderate to severe COPD/lung disease
- •Patients that remained intubated post-operatively
- •Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively
研究组 & 干预措施
SuperNO2VA nasal positive airway pressure device
Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm
干预措施: SuperNO2VA nasal positive airway pressure devic (Device)
Supplemental oxygen
5lpm of supplemental oxygen via a nasal cannula or face mask
干预措施: Supplemental oxygen (Device)
结局指标
主要结局
Hypoxemia
时间窗: Within 90 minutes of extubation between the two study groups.
Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute)
次要结局
- Airway maneuvers(Within 90 minutes of extubation)
- Post op respiratory complications(Within 90 minutes of extubation)
- Length of PACU stay(Within 24 hours of surgery)