NCT04852432Unknown不适用
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Desaturation (≤95%)
研究概览
简要总结
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under the age of 18 who undergo moderate-deep sedation
排除标准
- •Respiratory failure patients
- •Increased intracranial pressure
- •Recent massive nasal bleeding
- •History of airway surgery
- •Complete nasal obstruction
- •Pulmonary hypertension
- •Skull base fracture
研究组 & 干预措施
Low flow group
Experimental
Oxygen administration by nasal cannula
干预措施: nasal prong (Device)
High flow group
Experimental
Oxygen is administered at a rate of 2L/kg/min using an Optiflow device
干预措施: high flow nasal cannula (Device)
Control group
No Intervention
Nasal prong is applied, but sedation is performed without oxygen administration.
结局指标
主要结局
Desaturation (≤95%)
时间窗: through study completion, average 30 minutes
Occurrence of desaturation (pulse oximeter ≤95%)
次要结局
- Desaturation (≤90%)(through study completion, average 30 minutes)
- CO2 value(through study completion, average 30 minutes)
- Minimum saturation during sedation(through study completion, average 30 minutes)
- Complications(through study completion, average 30 minutes)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (1)
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