Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The change in pH observed during the prehospital treatment period.
研究概览
简要总结
The goal of this clinical trial is to test if treatment with prehospital Non-invasive ventilation (NIV) for patients with acute respiratory failure (ARF), due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) based on in-hospital criteria, should be used in the prehospital setting. This is performed with the introduction of prehospital arterial blood gas analyzation. The primary objective is:
• To determine if early prehospital applied NIV together with standard medical treatment will affect arterial pH at hospital arrival in patients with ARF due to AECOPD.
Participants in the intervention will receive Non-invasive ventilation together with standard medical treatment. The intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.
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
盲法说明
Due to the nature of the intervention, the clinicians performing the intervention cannot be blinded. This is also the case for patients along with any legally designated representatives at the scene. As it is common to note the prehospital treatment in the patient's medical records clinicians at the ED and/or ICU will not necessarily be blinded either. For the same reason, investigators involved in data entry will also not be blinded meaning that outcomes such as change in arterial pH are entered without blinding. However, there is little - if any - subjectivity in evaluating these outcomes and blinding is therefore likely of minor importance.
A patient - or alternatively the consenting legally designated representatives - will not be informed of the allocation until the end of follow-up and only per request on the consent form.
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
- •Age greater than or equal to 18 years.
- •Medical history of COPD.
- •Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
- •Respiratory acidosis with a PaCO2 of > 6,0 kPa and a pH of < 7,
- •And one of the following:
- •Respiratory rate of > 25 per minute.
- •Hypoxia with a PaO2 < 7 kPa and/or a saturation < 88% without oxygen administered.
排除标准
- •Upper gastrointestinal hemorrhage or vomiting.
- •Anatomical abnormality that precludes the use of an oro-nasal interface.
- •Suspicion of pneumothorax.
- •Cardiac or respiratory arrest.
- •Uncontrollable malignant arrhythmia.
- •Refractory shock (systolic blood pressure < 90 mmHg) despite fluids and/or vasoactive drugs given.
- •Required orotracheal intubation.
- •Suspected upper airway obstruction.
- •No indication for life-prolonging treatment with NIV.
结局指标
主要结局
The change in pH observed during the prehospital treatment period.
时间窗: During the prehospital treatment for a maximum of 2 hours.
pH will be measured before randomization in the prehospital setting and at arrival at the emergency department. The change in pH will be compared between the two groups.
次要结局
- Proportion treated with invasive respiratory treatment.(During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.)
- Length of hospital stay.(From time of admission and up until discharge. Assessed up to 30 days.)
- Mortality (in-hospital and 30 days after admission).(During the length of hospital stay and up until 30 days after admission.)
- Prehospital treatment time (both on-scene time and transport time).(During the prehospital treatment for a maximum of 2 hours.)
- Overall time with a NIV-mask on.(From time of randomization and during the entire admission. Assessed up to 30 days.)
- The change in pH 2 hours from the initial prehospital ABG analysis.(2 hours from the initial prehospital ABG analysis.)