High-Flow Nasal Cannula Flow Titration and Effort of Breathing in the Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
研究概览
简要总结
High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to decrease the effort of breathing (EOB) in patients with a wide variety of respiratory diseases in the pediatric intensive care unit. While its use has shown association with decreased rates of mechanical ventilation, there is a paucity of data examining its direct effect upon objective measurements of EOB. This study will aim to evaluate objective measurements of EOB in response to different levels of HFNC support, characterize the natural course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the administration of supplemental medical therapies used in conjunction with HFNC, and compare different physiologic metrics for quantifying EOB in patients on HFNC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants less than or equal to three years old admitted to the PICU placed on high flow nasal cannula will be considered eligible for the study.
排除标准
- •Participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or RIP bands (abdominal wall defects such as omphalocele). Patients greater than three years of age will be excluded.
结局指标
主要结局
Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
时间窗: median percent change in PRP over 5 minute measurement period
PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). The percent change in PRP is derived from the quotient of the absolute PRP at increased HFNC flow rates (1.0, 1.5, and 2.0 L/kg/min) divided by the absolute PRP at a baseline HFNC flow rate (0.5 L/kg/min). Percent change in PRP was used because a) there was a large degree of heterogeneity in baseline absolute PRP values in our study population based upon patient size, disease severity, and time point of illness, and b) we allowed for repeated measures on the same patient which would bias absolute PRP values in favor of those who were measured more frequently. It was not pre-specified to compare the two different HFNC delivery systems.
次要结局
- Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems(median PRP over a 5 minute period)
- Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)(median of the maximum percent change in PRP over a 5 minute period)
- Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)(median PRP over a 5 minute period)
- Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)(median phase angle over a 5 minute period)
- Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)(medain percent change in PRP over a 5 minute period)
研究者
Robinder Khemani
Principal Investigator
Children's Hospital Los Angeles