A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
研究概览
简要总结
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.
详细描述
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.
排除标准
- •Left ventricular Assist Device
- •Severe Pulmonary Hypertension
- •Ejection fraction less than 35 percent
- •Active Congestive Heart Failure Exacerbation
- •Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
- •Topical lidocaine administration
- •Pregnancy
- •Previous enrollment in this study
研究组 & 干预措施
Intervention: Nasal Mask
Nasal anesthesia mask with positive pressure
干预措施: Nasal Mask (Device)
Control: Nasal cannula
Nasal Cannula with standard care
干预措施: Control: Nasal Cannula (Device)
结局指标
主要结局
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
时间窗: Approximately 1 hour
Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.
次要结局
- Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring(Approximately 1 hour)
- Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy(Approximately 1 hour)
- Total Number of Hypoxic Events in Subjects That Experienced Hypoxia(Approximately 1 hour)
- Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring(Approximately 1 hour)
- Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation(Approximately 1 hour)
- Hypoxia Duration(Approximately 1 hour)
