National Institute of Respiratory Diseases Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Systemic Inflammation
研究概览
简要总结
INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical ventilation to the airway through non-invasive positive pressure ventilation (NIPPV) decreases bronchial hyperreactivity and contractility of smooth muscle.
OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic inflammation and the state of hypersensitivity in patients with asthma attack.
MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group), all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1 and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5, IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE) between both groups will be compared after 4 days of treatment.
详细描述
RESEARCH QUESTION What is the effect of non invasive positive pressure ventilation (NIPPV) on systemic inflammation in patients with asthma attacks?
JUSTIFICATION Asthma is a global public health problem and one of the primary causes of care at the National Institute of Respiratory Diseases in Mexico; when presented as a crisis is a serious condition that puts the life of the patient at risk; in vitro and in vivo studies have shown that the application of chronic airway distention using non-invasive mechanical ventilation produces a reduction in bronchial hyperreactivity in patients with asthma and may have a positive effect on the treatment of this condition independent of its effects on ventilation in the presence of acute respiratory failure.
HYPOTHESIS The use of NIPPV will improve systemic inflammation assessed by C reactive protein (CRP) in patients with severe asthmatic crisis.
OBJECTIVES
Main Objective:
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
- Double (Participant, Investigator)
盲法说明
Similar equipment will be used, the programming of the positive pressure device will be performed by an external person and a cover will be placed on the screen.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma, performed by a physician, with spirometry and stable treatment for at least 3 previous months.
- •Severe asthma crisis and hospitalization requirement of at least 4 days.
排除标准
- •Life-threatening crisis.
- •Requirement of Invasive or Non-Invasive Mechanical Ventilation.
- •High risk for Obstructive Sleep Apnea (measured through the Berlin questionnaire).
- •Active smoking.
- •Another chronic lung disease other than asthma.
- •Pneumonia (defined by the presence of an opacity of the lung parenchyma on a chest x-ray).
- •Ischemic heart disease.
- •Uncontrolled systemic arterial hypertension.
结局指标
主要结局
Systemic Inflammation
时间窗: 4 days
To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.
次要结局
- Hospitalization(4 days)
- Adherence(4 days)
- Gas Exchange(4 days)
- Local Inflammation(4 days)
- Serum Inflammation(4 days.)
研究者
Jose Luis Carrillo Alduenda
MD
National Institute of Respiratory Diseases, Mexico