2022-502003-30-00招募中4 期
STOP-COPD Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Præhospitalet1 个研究点 分布在 1 个国家目标入组 1,888 人开始时间: 2022年12月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,888
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
To determine whether prehospital titrated oxygen in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Confirmed suspicion of COPD
- •The treating EMT or Paramedic suspects AECOPD
- •Patients over the age of 40 years
- •Need of inhaled bronchodilators
排除标准
- •Non-COPD bronchospasm
- •Known or suspected pregnancy
- •Prehospital NIV, invasive or bag mask assisted ventilation
- •Allergy to inhalation drug (Salbutamol)
- •Transfer between hospitals
- •More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS personnel, before allocated treatment is initiated
- •Readmission within 30 days from last randomization
- •Suspicion of acute coronary syndrome (ACS)
- •Prior decline to participate in the trial
结局指标
主要结局
30-day mortality
30-day mortality
次要结局
- 24-hour mortality
- 7-day mortality
- Length of hospitalization
- ICU admission rate
- Length of ICU admission
- In-hospital need for NIV within 24 hours, 7 days and 30 days
- Time to NIV
- In-hospital need for invasive mechanical ventilation within 24 hours, 7 days and 30 days
- Time to invasive ventilation
- Proportion of patients with respiratory acidosis on arrival to hospital
- The degree of acidosis based on the pH-value
- Patient experienced dyspnoea on a verbal rating scale 0-10
- Readmission rate
- Time to readmission
研究者
Martin Faurholt Gude
Scientific
Præhospitalet
研究点 (1)
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