Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
研究概览
简要总结
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.
A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
详细描述
Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.
because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).
Authors MEAN AGE
(yrs) TYPE of STUDY
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age higher 75 years old
- •Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
- •Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
排除标准
- •Respiratory failure due to pulmonary oedema
- •Kelly's score equal or higher than 4
- •Cardio-respiratory arrest
- •Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
- •Recent facial, oesophageal and gastric surgery
研究组 & 干预措施
1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
干预措施: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option (Device)
1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
干预措施: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed (Drug)
2
standard therapy + oxygen
干预措施: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed (Drug)
结局指标
主要结局
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
时间窗: 3 months
次要结局
- Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay(3 months)