A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Respiratory Assessment Change Score (RACS)
研究概览
简要总结
This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 2-12 months of age presenting to Emergency Department
- •Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
- •Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist
排除标准
- •Previous history of wheezing
- •Known heart or lung disease
- •Premature birth defined as birth before 37 weeks gestation
- •Immunosuppression or immunodeficiency
- •Treatment with corticosteroids in the previous 48 hours
- •Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
- •Oxygen saturation <85% on room air at the time of recruitment
研究组 & 干预措施
3% hypertonic saline group
Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.
干预措施: 3% Hypertonic Saline (Drug)
0.9% normal saline group
Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.
干预措施: 0.9 % normal saline (Drug)
结局指标
主要结局
Respiratory Assessment Change Score (RACS)
时间窗: 5-15 minutes
The primary outcome variable is the Respiratory Assessment Change Score (RACS) which is a sum of the change in the Respiratory Distress Assessment Instrument (RDAI)score plus a standardized score for the change in respiratory rate; the change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate.The RDAI score is the sum of the row scores, with total range 0 to 17; higher scores indicate more severe disease.
次要结局
- Rate of Hospitalizations(24 hours)