A Prospective, Randomized, Controlled, Single Center Trial of the Use of Heliox in Children Admitted to the Hospital With Status Asthmaticus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.
详细描述
We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation >90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique:
Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.
Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 -18 years;
- •Previous history of asthma;
- •Hospital admission for acute asthma exacerbation;
- •Clinical asthma score greater than or equal to 3
排除标准
- •Less than 2 years old or over 18 years old;
- •Known allergy or hypersensitivity to ß-agonists;
- •Require mechanical ventilation (invasive or non-invasive);
- •Require FiO2 >0.4;
- •Failure to obtain informed consent;
- •Enrollment in another investigational drug or asthma protocol;
- •Incipient respiratory failure including but limited to respiratory acidosis(pCO2>60 torr), altered mental status and/or excessive work of breathing.
研究组 & 干预措施
Group 1 (Heliox-powered albuterol)
Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.
干预措施: Helium-oxygen-driven albuterol nebulizer (Drug)
Group 2 (Oxygen-powered albuterol)
Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
干预措施: Oxygen (Drug)
结局指标
主要结局
Length of Stay
时间窗: Hospital discharge
Time to discharge eligibility (hours)
次要结局
未报告次要终点