HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
研究概览
简要总结
The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis.
The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.
详细描述
Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia.
The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance.
Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR).
Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages ≤24 months of age
- •Physician diagnosed bronchiolitis
- •Admitted to pediatric floor
- •Supplemental oxygen requirement, <4 L/min, for hypoxemia, oxygen saturation <92% in room air
排除标准
- •Prematurity, born <37 weeks gestational age
- •Admitted to pediatric intensive care unit for medical indication
- •Requirement of heated, humidified high flow system
- •Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement)
- •Neuromuscular disorders
- •Chromosomal defects
- •Metabolic disorders
- •Immunodeficiency
- •Unrepaired cardiac abnormalities
研究组 & 干预措施
Standard oxygen via nasal cannula
Standard therapy
Heated and humidified oxygen
Heated and humified oxygen
干预措施: Heated and humidified oxygen (Device)
结局指标
主要结局
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
时间窗: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.
Change in Respiratory Rate (RR) From Baseline
时间窗: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.
次要结局
- Length of Hospital Stay(Subjects will be followed for the duration of hospital stay until discharge)
- Duration of O2 Use(Subjects will be followed for the duration of oxygen requirement until oxygen discontinued)
研究者
Diana Chen
Pediatric Pulmonary Fellow
UCSF Benioff Children's Hospital Oakland