Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome
研究概览
简要总结
Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population.
Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome
排除标准
- •Contraindication to adhesive placement, eg, epidermolysis bullosa
- •Patient or parent refusal
- •Heart rate altering therapy such as beta blockers
- •During the study period, participants will abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for [6 hours] before the start of the anesthetic.
- •Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.
结局指标
主要结局
Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome
时间窗: Immediately upon entry into Same Day Surgery patient room
Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery.
Operating room feasibility of VU-AMS monitor on patients with Down Syndrome
时间窗: Immediately prior to mask induction with sevoflurane
Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room
Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome
时间窗: Beginning at time of bradycardia and continuing for the next 300 seconds.
Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%
Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome
时间窗: Immediately upon entry into Same Day Surgery patient room
Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery.
Operating room feasibility of VU-AMS monitor on patients without Down Syndrome
时间窗: Immediately prior to mask induction with sevoflurane
Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room
Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome
时间窗: Beginning at time of bradycardia and continuing for the next 300 seconds.
Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%
次要结局
未报告次要终点