High-flow Nasal Oxygen Versus Face Mask or Nasal Cannula for Advanced Endoscopy in High-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Additional actions had to be taken to ensure sufficient SpO2 oxygenation.
研究概览
简要总结
Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation.
This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.
详细描述
This non-blinded, randomized controlled trial compares two study groups, the interventional and control group, to investigate whether HFNO-treatment reduces the risk of hypoxemia during peri-interventional high-risk upper GI endoscopy.
The randomization schema is developed by an unblinded statistician using SAS (Statistical system) and uploaded to the REDCap randomization module, enabling delegated team members to generate sequential allocations for enrolled subjects.
Patients assigned to the control group will receive supplemental oxygen throughout anesthesia in accordance with hospital guidelines, either using a standard nasal cannula or procedural oxygen mask (POM). The choice of supplemental oxygen delivery, as well as oxygen flow rates, are at the discretion of the anesthesia provider. Post-anesthesia, patients will be transferred to the recovery room with either the standard nasal cannula or procedural oxygen mask at a flow rate determined by the anesthesia provider.
Patients assigned to the intervention group will receive humidified oxygen throughout anesthesia in order to assess the effect of HFNO. High-flow nasal cannula (Fisher & Paykel Optiflow) are connected prior to induction of anesthesia, allowing for different flow rates and oxygen concentration to be administered according to the study protocol. The oxygen concentration of the delivered gas for the trial is 100%. Prior to induction, flow rate will be set to 20 liters per minute and increased to 30 liters per minute if tolerated by the patient. After induction of anesthesia, flow rate will be increased to 60 liters per minute and maintained throughout anesthesia. After anesthesia, the high-flow nasal cannula will be exchanged to a standard nasal cannula and the patient will be transferred to the recovery room at which point the flow rate will be determined by the anesthesia provider.
The decision to discontinue the intervention of the study is entirely at the discretion of the attending anesthesiologist. Alternative means of supplemental oxygen delivery, such as nasal cannula or oxygen mask, may be considered by the attending anesthesiologist. If the intervention is discontinued, the rationale for the decision is documented for later analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Upper endoscopy (EGD, ERCP, EUC etc.) w/wo colonoscopy expected duration > 15 min under MAC
- •one or more of the following:
- •Diagnosis of sleep apnea
- •BMI ≥ 30 kg/m2
- •Baseline SpO2 < 96% or Requirement for long-term oxygen therapy
- •BOSTN score ≥ 2
- •BMI ≥ 30 kg/m2
- •Observed apnea
- •Observed loud Snoring
- •Daytime Tiredness
- •Neck circumference ≥ 16.5 inches in female, ≥ 17.5 inches in male
排除标准
- •Known Pregnancy
- •Known Current infection with COVID-19
- •Planned general anesthesia
结局指标
主要结局
Additional actions had to be taken to ensure sufficient SpO2 oxygenation.
时间窗: The primary outcome will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes
A composite outcome including the occurrence of any airway manipulation due to inadequate ventilation, which may include jaw thrust or Esmarch maneuver, bag-mask ventilation, insertion of a nasogastric tube, laryngeal mask airway or endotracheal intubation or procedural interruption to treat inadequate ventilation. The necessity for airway manipulation is at the discretion of the anesthesia provider. Documentation of the primary outcome is conducted on paper sheets by the anesthesia provider including time, type and reason of upper airway manipulation.
次要结局
- Satisfaction of care provider(Satisfaction of the provider will be assessed at the end of the procedure upon discharge from the procedure room and will relate to the duration of the procedure, typically between 30 and 120 minutes)
- Procedure interruption(Procedure interruption will be assessed for the duration of the procedure, which is typically between 30 and 120 minutes)
- Occurrence of hypoxemia(The occurence of hypexmia will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes)
研究者
Maximilian S Schaefer
Director of the Center for Anesthesia Research Excellence (CARE), Division Director of Thoracic Anesthesia, Assistant Professor of Anesthesia
Beth Israel Deaconess Medical Center