7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
研究概览
简要总结
Study Design: This randomized, double blind, controlled, multi-centre study will occur in the Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics (collectively "ED") of 3 General Hospitals in Ontario and 1 in British Columbia.
详细描述
Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. Recruitment will only occur when Research Assistants are on duty, is projected to include regular working hours Monday-Friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). Initial routine assessment by the ED staff will identify potential subjects and Research Assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. Recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.
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
- 4 Weeks 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 2 years
- •History of viral upper respiratory infection within previous 7 days
- •Wheezing or crackles detected on chest auscultation
- •Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
排除标准
- •History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- •Severe illness at presentation as defined by any of the following Respiratory rate greater than 80/min SaO2 less than 88% in room air Need for assisted ventilation Use of nebulized HS within previous 12 hours Previous enrollment in this study.
结局指标
主要结局
The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
时间窗: 120 minutes after baseline pre-treatment
The response to treatment is determined by using the Respiratory Distress Assessment Instrument(RDAI) score and respiratory rate to calculate the Respiratory Assessment Change Score (RACS) i.e. RDAI score before minus RDAI score after treatment
次要结局
- length-of-stay of admitted patients(28 days)
- rates of unscheduled return for respiratory illness to the ED(14 days)
- rates of admission to hospital(7 days)
研究者
Dr. Michael Flavin
Principal Investigator
Queen's University
