Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Titrated Oxygen, Standard Oxygen.
- Кому может быть актуально
- Состояния в реестре: COPD Exacerbation, COPD Exacerbation Acute. Базовые параметры: от 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
The study is conducted under emergency research regulations allowing enrolment before informed consent, with consent obtained as soon as feasible after hospital admission. This trial seeks to evaluate whether titrating oxygen delivery in the prehospital phase can improve survival and clinical outcomes for patients with AECOPD.
Вмешательства
- Препарат Titrated Oxygen
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92% - Препарат Standard Oxygen
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Первичные конечные точки
- Mortality, 30-day [Срок оценки: Day 30 from randomization]
Вторичные конечные точки (12)
- Mortality, 24-hour [Срок оценки: 24 hours from randomization]
- Mortality, 7-day [Срок оценки: Day 7 from randomization]
- Length of hospital stay [Срок оценки: Day 30 from randomization]
- ICU admission rate [Срок оценки: Day 30 from randomization]
- Length of ICU stay [Срок оценки: Day 30 from randomization]
- In-hospital need for NIV (non-invasive ventilation) within 24 hours [Срок оценки: Day 30 from randomization]
- In-hospital need for NIV within 7 days [Срок оценки: Day 30 from randomization]
- In-hospital need for NIV within 30 days [Срок оценки: Day 30 from randomization]
- Time to NIV [Срок оценки: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 24 hours [Срок оценки: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 7 days [Срок оценки: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 30 days [Срок оценки: Day 30 from randomization]
Критерии участия
Критерии включения
- Patients over the age of 40
- EMT or Paramedic suspected AECOPD
- Confirmed suspicion of COPD
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Prehospital Emergency Medical Servises, Central Denmark Region — Aarhus N
Публикации
- Jensen ASR, Valentin JB, Mulvad MG, Hagenau V, Skaarup SH, Johnsen SP, Vaeggemose U, Gude MF. Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial. Trials. 2024 Jan 25;25(1):85. doi: 10.1186/s13063-024-07920-5. PMID 38273393
Идентификаторы
NCT: NCT05703919 · 5925 · 2022-502003-30-00