A Randomized Controlled Trial Comparing Helmet Continuous Positive Airway Pressure (CPAP) vs Facemask CPAP for Treatment of Acute Cardiogenic Pulmonary Edema In The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 主要终点
- Respiratory Rate
研究概览
简要总结
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.
详细描述
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema
排除标准
- •Age less than 18 years old
- •Low GCS (less than 8), altered mental status
- •Hemodynamic instability, impending cardiopulmonary arrest
- •Use of vasopressors, inotropes
- •Exacerbation of asthma or chronic respiratory failure
- •Urgent need for endotracheal intubation
- •Absence of airway protective gag reflex
- •Elevated intracranial pressure
- •Tracheostomy
- •Upper airway obstruction
- •Injuries or surgery to head and neck less than 6 months upon presentation
- •Claustrophobia
- •Blind or poor vision
- •Medico-legal related cases
研究组 & 干预措施
helmet CPAP
helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
干预措施: hCPAP vs fCPAP (Device)
facemask CPAP
facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
干预措施: hCPAP vs fCPAP (Device)
结局指标
主要结局
Respiratory Rate
时间窗: 1 hour
Respiratory rate change post intervention
次要结局
- Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen(1 hour)
- Dyspnea Scale(1 hour)
- Heart Rate(1 hour)
- Partial Pressure of Arterial Oxygen Level(1 hour)
- Partial Pressure of Arterial Carbon Dioxide level(1 hour)
- Rate of Intubation(1 hour)
研究者
Dr. Adi Bin Osman
Emergency Medicine Consultant
Hospital Raja Permaisuri Bainun