Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 5
- 主要终点
- Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
研究概览
简要总结
THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. The use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. This study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries
排除标准
- •Pregnancy
- •Absence of parent or legal guardian able to provide written consent for study participation
- •Anatomical or surgical contraindications (epistaxis, basilar skull fractures or abnormalities, nasal surgery or obstruction, nasal fractures, nasal vascular abnormalities), tracheostomy tube
- •Emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.
研究组 & 干预措施
Control
Control subjects will undergo their scheduled procedure and recovery with the usual care. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives.
Intervention
Treatment subjects will undergo the scheduled procedure, with the difference being that a high-flow nasal cannula will be applied prior to the start of the procedure and removed following the procedure's conclusion. While applied, the cannula will deliver high- flow rate oxygen, air, or a mixture of variable oxygen concentration (21-100%) depending on the surgical conditions and requirements. The rate will be set at 1-4L/kg/min with a maximum of 70L/min. Participants in the treatment arm will then proceed to the recovery area as usual. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives.
Intervention: Device: High-flow nasal cannula
干预措施: Transnasal Humidified Rapid-Insufflation Ventilatory Echange (Device)
结局指标
主要结局
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
时间窗: Duration of surgery or procedure, which is generally less than 2 hours
Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.
Number of Participants With Desaturations <90%
时间窗: Duration of surgery or procedure, which is generally less than 2 hours
Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed.
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
时间窗: Duration of surgery or procedure, which is generally less than 2 hours
Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed. Participants who experienced both a fall below 90% O2 and a 4% drop below baseline saturation are reported as having more than 1 event.
次要结局
- Number of Participants With Surgical Interruptions Due to Desaturation(Duration of surgery or procedure, which is generally less than 2 hours)
- Minimum Oxygen Saturation as a Measure of Desaturation Severity(Duration of surgery or procedure by second, which is generally less than 2 hours)
- Time-normalized Area Under Curve (AUC) of Desaturations <90%(Duration of surgery or procedure, which is generally less than 2 hours)
研究者
Thomas Caruso
Clinical Associate Professor
Stanford University