Comparison of the incidence of hypoxemia during sedated gastrointestinal endoscopy: Nasopharyngeal airway with nasal cannula versus nasal cannula alone : A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- The primary outcome will be the incidence of hypoxemia during the procedure, defined as SPO2 less than 90. Hypoxemia will be considered clinically significant if the duration of low SPO2 exceeds 1 minute.
研究概览
简要总结
Gastrointestinal endoscopy, a widely performed diagnostic and therapeutic procedure, is often done under sedation. However, sedation can lead to respiratory depression and hypoxemia, a condition where blood oxygen levels fall below normal. Although oxygen supplementation using nasal cannulas is common practice, it may not be sufficient to prevent hypoxemia in some patients. The nasopharyngeal airway (NPA) is a device that may provide an airway for oxygenation comparable to standard nasal cannula delivery during gastrointestinal endoscopy with sedation. The present study will determine whether the addition of the NPA offers significant advantages in preventing hypoxemia by comparing outcomes between patients receiving standard oxygen delivery (standard nasal cannula) and those receiving oxygen via both a standard nasal cannula and an NPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing gastrointestinal endoscopy Patients accepted in ASA classification I to III.
排除标准
- •History of upper respiratory tract infection in the past two weeks Severe chronic obstructive pulmonary disease or acute attack of asthma Baseline oxygen saturation less than 90% when inhaling air History of allergy to eggs, soy, albumin or sedatives Nasal obstruction and cannot effectively inhale oxygen through the nose Congenital anomalies affecting the anatomy of the airways Pregnancy or lactation Glaucoma.
结局指标
主要结局
The primary outcome will be the incidence of hypoxemia during the procedure, defined as SPO2 less than 90. Hypoxemia will be considered clinically significant if the duration of low SPO2 exceeds 1 minute.
时间窗: From induction of sedation to the end of the gastrointestinal endoscopy procedure
次要结局
- Any additional measures required to manage hypoxemia, such as increasing oxygen flow or manual ventilation, will be recorded and record adverse events related to sedation or the use of the NPA(From induction of sedation to the end of the gastrointestinal endoscopy procedure)
研究者
Varsha Balachandran
Armed Forces Medical College