Efficacy of Nebulized Heparin and Salbutamol in Mechanically Ventilated Patients With Acute Exacerbation Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The number of ventilator hours
研究概览
简要总结
This randomised study was designed to assess the efficacy of nebulised heparin and salbutamol in improving lung function in mechanically ventilated patients with AECOPD.
详细描述
Methods:
Patients:
This study was performed between February 2017 and September 2017. Admitted Patients to the Internal Medicine ICU of Ain-Shams University Hospitals were screened for meeting enrollment criteria. Written informed consent was taken from all patients, their parents or their guardians before any study procedure was done. Patients were included in the study if they were > or = 18 years of age, body weight 70-110Kg, height 160-180 cm with clinically evident AECOPD and in need for mechanical ventilation confirmed by arterial blood gases (ABGs).
Excluded Patients from the study were those who were not enrolled within the first 24 hours of mechanical ventilation and those who were likely to be extubated within 24 hours. Patients were also excluded if they have any history of ischemic heart disease, pulmonary bleeding within the previous 3 months, history of bleeding diathesis, known to be allergic to heparin or history of thrombocytopenia after previous treatment with heparin. Female patients were excluded if they are pregnant or breast feeding.
Study design:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or = 18 years of age,
- •body weight 70-110Kg,
- •height 160-180 cm
- •with clinically evident AECOPD and in need for mechanical ventilation confirmed by arterial blood gases (ABGs).
排除标准
- •Excluded Patients from the study were those who were not enrolled within the first 24 hours of mechanical ventilation and those who were likely to be extubated within 24 hours. - History of ischemic heart disease,
- •History of pulmonary bleeding within the previous 3 months,
- •History of bleeding diathesis,
- •Known to be allergic to heparin or
- •History of thrombocytopenia after previous treatment with heparin.
- •Female patients were excluded if they were pregnant or breast feeding.
研究组 & 干预措施
HS Group (study group)
干预措施: Nebulized heparin and salbutamol (Drug)
S Group (control group)
干预措施: Nebulized salbutamol (Drug)
结局指标
主要结局
The number of ventilator hours
时间窗: Maximum of 14 days from randomization.
Number of hours during which the patient was mechanically ventilated.
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Lecturer of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University