Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Heart Rate in Beats Per Minute
研究概览
简要总结
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
详细描述
A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions
排除标准
- •Known allergy or sensitivity to study medications
- •Baseline heart rate was greater than 110 beats per minute
研究组 & 干预措施
Levalbuterol 0.63
Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
干预措施: Levalbuterol (Drug)
Levalbuterol 0.63
Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg.
干预措施: Albuterol (Drug)
Levalbuterol 1.25
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
干预措施: Levalbuterol (Drug)
Levalbuterol 1.25
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
干预措施: Albuterol (Drug)
结局指标
主要结局
Heart Rate in Beats Per Minute
时间窗: Five days
Average difference in Heart rate between pre and post breathing treatments
次要结局
- Arrhythmias(15 minutes after each treatment for average of 3 to 5 days)
- Total Number of Participants With Arrhythmias(Five days)
研究者
Fahim Khorfan, MD
ICU Pulmonologist
Ascension Health