A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Pediatric Asthma Score
研究概览
简要总结
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-18 years old
- •For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
- •For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
- •Acute asthma exacerbation
- •Pediatric Asthma Score (PAS) ≥ 8
- •Parents willing and able to sign consent
- •Children over the age of 6 willing to provide assent
排除标准
- •History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
- •History of sickle cell disease
- •Recently diagnosed pneumonia
- •Current tracheostomy, on home ventilator or home oxygen requirement
- •Recent diabetic ketoacidosis
- •Requiring immediate intubation
- •Weight less than 5 kilograms
- •Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway
- •A history of prematurity of ≤ 30 weeks gestation
研究组 & 干预措施
Sham NIPPV
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.
干预措施: Volumetric CO2 (NM3) (Device)
Control
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol.
干预措施: USCOM (Device)
Sham NIPPV
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.
干预措施: NIPPV (PALMtop PTV) (Device)
Sham NIPPV
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.
干预措施: USCOM (Device)
BiPAP
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.
干预措施: NIPPV (PALMtop PTV) (Device)
BiPAP
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.
干预措施: Volumetric CO2 (NM3) (Device)
BiPAP
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.
干预措施: USCOM (Device)
结局指标
主要结局
Change in Pediatric Asthma Score
时间窗: Every 30 minutes while the subject is enrolled
The primary outcome indicator will be a decrease in PAS to ≤ to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 ≤ in BiPAP group is 5 hours; median expected time to PAS ≤ 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.
次要结局
- Volumetric end tidal CO2 trend(Continuous while the subject is enrolled)
- Respiratory parameters(Continuous while the subject is enrolled)
- Cardiac output(Continuous while the subject is enrolled)
- Intubation and complication rates(Continuous observation)
- Length of hospital stay(Retrospectively upon completion of study)