Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 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 Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC.
详细描述
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
HFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
结局指标
主要结局
Respiratory Rate
时间窗: 1 hour
Respiratory rate reduction post intervention
次要结局
- Heart Rate(1 hour)
- Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score(1 hour)
- Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen(1 hour)
- Dyspnoea Scale(1 hour)
- Partial Pressure Of Arterial Oxygen Level(1 hour)
- Rate Of Intubation(1 hour)
- 28-Days Mortality In Acute Cardiogenic Pulmonary Edema(28 days)
研究者
Dr. Adi Bin Osman
EMERGENCY MEDICINE CONSULTANT
Hospital Raja Permaisuri Bainun