Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- pH at 1+ hour
研究概览
简要总结
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
详细描述
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
排除标准
- •< 18 years old
- •pH < 7.25
- •need for immediate intubation
- •uncontrolled cardiac failure
- •hypotensive (systolic blood pressure < 90mmHg)
- •acute myocardial infarction
- •acute dysrhythmia
- •other system failure (e.g. acute renal failure, liver failure)
- •moderate or severe bulbar weakness
- •inability to understand rationale and/or consent form for study
研究组 & 干预措施
autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
干预措施: AutoVPAP™ (Device)
Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
干预措施: VPAPIIIST-A™ (Device)
结局指标
主要结局
pH at 1+ hour
时间窗: 1 hour
pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
次要结局
- pH at 4+ hours(4+ hours of NIV treatment)
- Respiratory Rate at 1+ hour(1+ hour of NIV treatment)
- Respiratory rate at 4+ hours(4+ hours of NIV treatment)
- overnight mean transcutaneous carbon dioxide(24 hours)
- PaCO2 at 1+ hours(1+ hours of NIV treatment)
- PaCO2 at 4+ hours(4+ hours of NIV treatment)
- PaO2 at 1+ hour(1+ hour of NIV treatment)
- PaO2 at 4+ hours(4+ hours of NIV treatment)