Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
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
- Mortality, 30-day
研究概览
简要总结
The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.
详细描述
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality globally. In the prehospital setting, patients with suspected acute exacerbation of COPD (AECOPD) are frequently treated with inhaled bronchodilators driven by 100% oxygen, despite concerns that high-concentration oxygen therapy may worsen hypercapnia and acidosis, leading to increased mortality.
The STOP-COPD trial is a prospective, randomized, parallel-group, superiority trial conducted in the Prehospital Emergency Medical Services, Central Denmark Region. Patients aged 40 years or older with suspected AECOPD requiring inhaled bronchodilators are randomized 1:1 to receive either:
Titrated oxygen therapy: Inhaled bronchodilators driven by compressed air with supplemental oxygen titrated to maintain SpO₂ 88-92%.
Standard treatment: Inhaled bronchodilators driven by 100% compressed oxygen according to standard protocols.
The primary outcome is 30-day all-cause mortality. Secondary outcomes include 24-hour and 7-day mortality, need for invasive or non-invasive ventilation, development of respiratory acidosis upon hospital arrival, ICU admission rate, length of hospital and ICU stay, patient-experienced dyspnoea, and readmission rates. A total of 1,888 patients will be enrolled.
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
- Single (Participant)
盲法说明
The trial will be single blinded. The patients will be blinded to treatment allocation. The EMTs (emergency medical technicians) or paramedics will not be blinded because of practical, ethical and security problems with carrying compressed gas without known content in an ambulance. As part of study informed and training, the EMT's and paramedics will be attentive to keep all AECOPD suspected patients blinded to the treatment allocated.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 40
- •EMT or Paramedic suspected AECOPD
- •Confirmed suspicion of COPD
排除标准
- •Bronchospasm due to asthma, allergic reaction or non-COPD conditions
- •Known or suspected pregnancy
- •Prehospital Non-invasive, invasive or assisted bag mask ventilation
- •Allergy to inhaled bronchodilators (Salbutamol)
- •Inter-hospital transfer
- •More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated
- •Suspicion of acute coronary syndrome
研究组 & 干预措施
Titrated Oxygen
If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures).
Following scenarios regarding SpO2 can occur during treatment:
SpO2 <88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter.
SpO2 88-92%: No intervention.
SpO2 >92%: No intervention.
If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.
干预措施: Titrated Oxygen (Drug)
Standard Oxygen
If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP.
Following scenarios regarding SpO2 can occur during treatment:
SpO2 <88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min.
SpO2 88-92%: No intervention.
SpO2 >92%: No intervention.
If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.
干预措施: Standard Oxygen (Drug)
结局指标
主要结局
Mortality, 30-day
时间窗: Day 30 from randomization
Vital status assessed 30 days after randomization using hospital electronic medical records
次要结局
- Mortality, 24-hour(24 hours from randomization)
- Mortality, 7-day(Day 7 from randomization)
- Length of hospital stay(Day 30 from randomization)
- ICU admission rate(Day 30 from randomization)
- Length of ICU stay(Day 30 from randomization)
- In-hospital need for NIV (non-invasive ventilation) within 24 hours(Day 30 from randomization)
- In-hospital need for NIV within 7 days(Day 30 from randomization)
- In-hospital need for NIV within 30 days(Day 30 from randomization)
- Time to NIV(Day 30 from randomization)
- In-hospital need for invasive mechanical ventilation within 24 hours(Day 30 from randomization)
- In-hospital need for invasive mechanical ventilation within 7 days(Day 30 from randomization)
- In-hospital need for invasive mechanical ventilation within 30 days(Day 30 from randomization)
- Time to invasive ventilation(Day 30 from randomization)
- Proportion of patients with respiratory acidosis on arrival to hospital(Day 30 from randomization)
- The degree of acidosis based on the pH (potential of hydrogen) value(Day 30 from randomization)
- Patient experienced dyspnoea on a verbal rating scale 0-10(Day 30 from randomization)
- Readmission rate(Day 30 after discharge)
- Time to readmission(Day 30 after discharge)