Weaning Oxygen Therapy With Model-based Adaptive Control
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Duration of hyperoxia
研究概览
简要总结
The study is designed to evaluate the feasibility, safety and clinical utility of using an adaptive model to wean oxygen by computer assistance. Investigators hypothesize that weaning oxygen using this model will decrease duration of exposure to hyperoxia, decrease duration of exposure to hypoxia, decrease exposure to increased oxygen requirement, and decrease the number of manual fraction of inspired oxygen (FiO2) adjustments as compared to manual weaning of oxygen therapy.
详细描述
Investigators will perform a feasibility study followed by a randomized, controlled study on critically ill neonatal and pediatric patients on oxygen therapy.
Investigators will use a model-based adaptive control architecture to regulate FiO2 settings. A major advantage of using an "adaptive" control system is that the response of the patient to previous FiO2 settings are used to recompute the most appropriate FiO2 setting in fixed time intervals. As a result of this iterative and self-correcting process, the FiO2 value converges to the most appropriate value over a period of time.
Study Population:
Children <18 years of age admitted to the pediatric intensive care unit requiring oxygen therapy.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to 2 years of age
- •Admission to pediatric intensive care unit
- •Oxygen therapy with FiO2 >0.21 via high flow nasal cannula >4 litres per minute (LPM) oxygen or via mechanical ventilation
排除标准
- •No supplemental oxygen requirement or less than 4 LPM oxygen by nasal cannula
- •Congenital cardiac disease
- •Pulmonary hypertension
- •Hemodynamic instability requiring intervention
- •Respiratory status deemed too tenuous for weaning by attending physician
- •Ward of the state
结局指标
主要结局
Duration of hyperoxia
时间窗: Entire study (anticipated as 2 years).
Duration of time patients exposed to hyperoxia
次要结局
- Oxygen saturation in target range(Entire study (anticipated as 2 years).)
- Increased oxygen requirement(Entire study (anticipated as 2 years).)
- Time of increased oxygen requirement(Entire study (anticipated as 2 years).)
- Hypoxia incidence(Entire study (anticipated as 2 years).)
- Duration of hypoxia(Entire study (anticipated as 2 years).)
- Manual adjustments(Entire study (anticipated as 2 years).)
研究者
Azadeh Fayazi
Clinical Assistant Professor
Stanford University