Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Titrated Oxygen, Standard Oxygen.
- Who it may be relevant to
- Registry conditions: COPD Exacerbation, COPD Exacerbation Acute. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Drug Titrated Oxygen
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92% - Drug Standard Oxygen
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Primary outcome measures
- Mortality, 30-day [Time frame: Day 30 from randomization]
Secondary outcome measures (12)
- Mortality, 24-hour [Time frame: 24 hours from randomization]
- Mortality, 7-day [Time frame: Day 7 from randomization]
- Length of hospital stay [Time frame: Day 30 from randomization]
- ICU admission rate [Time frame: Day 30 from randomization]
- Length of ICU stay [Time frame: Day 30 from randomization]
- In-hospital need for NIV (non-invasive ventilation) within 24 hours [Time frame: Day 30 from randomization]
- In-hospital need for NIV within 7 days [Time frame: Day 30 from randomization]
- In-hospital need for NIV within 30 days [Time frame: Day 30 from randomization]
- Time to NIV [Time frame: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 24 hours [Time frame: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 7 days [Time frame: Day 30 from randomization]
- In-hospital need for invasive mechanical ventilation within 30 days [Time frame: Day 30 from randomization]
Eligibility criteria
Inclusion criteria
- Patients over the age of 40
- EMT or Paramedic suspected AECOPD
- Confirmed suspicion of COPD
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Prehospital Emergency Medical Servises, Central Denmark Region — Aarhus N
Publications
- 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
Identifiers
NCT: NCT05703919 · 5925 · 2022-502003-30-00