Improvement of Respiratory Muscle Function With Noninvasive Ventilation in Exacerbated COPD Patients Presenting Hypercapnic Respiratory Failure Without Acidosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Respiratory muscle function.
研究概览
简要总结
There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment of severe exacerbations of COPD presenting respiratory acidosis.
The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in patients with COPD exacerbation and hypercapnic respiratory failure without acidosis requiring hospital admission. It is known that NIV improves respiratory mechanics, so the primary outcome will be respiratory muscle function.
All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory failure without acidosis will be included for a period of 12 months. The patients will be randomized into two groups (conventional treatment or conventional treatment plus NIV). Clinical data, blood gases, muscle strength parameters will be collected at the inclusion time and 24h after starting NIV. Quality of life and hospital stay will be measured at discharge. All patients will be followed for a year.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD according to international guidelines ( GOLD)
- •COPD exacerbation requiring hospitalization
- •Initial blood gases: PaCO2> 50 mm Hg and pH> 7.
- •If the patient does not have COPD diagnosis at the time of inclusion, it could be included if the diagnosis is confirmed within three months after the exacerbation.
排除标准
- •Patients with a pH below 7.35
- •Patients with intubation criteria
- •Other chronic respiratory diseases (fibrothorax, cystic fibrosis, significant ribcage alterations)
- •Neuromuscular Diseases
- •Significant associated chronic systemic diseases (severe liver disease, chronic renal failure requiring dialysis, severe heart disease and active neoplasia)
- •COPD exacerbation secondary to pulmonary embolism, pneumonia or pneumothorax
- •Patients in active treatment with CPAP or home ventilation
结局指标
主要结局
Respiratory muscle function.
时间窗: At baseline, at discharge (average of 8 days), 6 months and one year later.
Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.
次要结局
- Days of hospitalization.(At discharge (average of 8 days).)
- Dyspnea scale questionnaire(At baseline, at discharge, 6 months and one year later.)
- Quality of life(At baseline, 6 months and one year later.)
- Blood gases(At baseline and at discharge (average of 8 days).)
- Number of hospital readmissions in the next year(At one year after discharge (average of 8 days).)