Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- mechanical ventilation and intubation
研究概览
简要总结
The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay
详细描述
Immunocompromised patients with a hematological malignancy that requiring admission in intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure was estimated between 20- 50 per cent of all admitted in hospital.
The survival rate of this patients that requiring mechanical ventilation is very poor.
In many cases the immunodepression with a great improvement in severe complication as infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone marrow transplantation and stem cell transplantation ) .
Pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all patient with acute respiratory failure (ARF) .
The trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50% to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a power of 80 %.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .
- •SaO2 less than 95% ( a.a.) ,
- •Respiratory rate (RR ) more than 25 breaths/minute .
排除标准
- •NYHA class II- III- IV or unstable angina or MI
- •Valvular heart disease or cardiac surgery ( previous 3 months)
- •Implanted cardiac pacemaker
- •BMI less than 40
- •History of dilated cardiomyopathy or CPE
- •Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , FEV1 < 50 %)
- •Diagnosis of sleep or neuromuscular disorders.
- •Claustrophobia .
- •Mechanical ventilation criteria:
- •Severe hypoxemia (arterial oxygen saturation < 80 % with maximal FiO2 )
- •Ph < 7.3 with a PaCO2 > 50 mmHg
- •Signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement
- •RR > 35 breaths/minute .
结局指标
主要结局
mechanical ventilation and intubation
次要结局
- Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality