COPD Exacerbation, COPD Exacerbation Acute
Conditions
Keywords
Titrated Oxygen, COPD Exacerbation, Prehospital, COPD
Brief summary
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
DRUGTitrated Oxygen
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
DRUGStandard Oxygen
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Sponsors
Central Denmark Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality, 30-day | Day 30 from randomization | Vital status assessed 30 days after randomization using hospital electronic medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality, 7-day | Day 7 from randomization | Vital status assessed 7 days after randomization using hospital electronic medical records |
| Length of hospital stay | Day 30 from randomization | Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records |
| ICU admission rate | Day 30 from randomization | Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record |
| Length of ICU stay | Day 30 from randomization | Number of days spent in the intensive care unit during the index hospitalization, collected from the patient's electronic hospital medical record |
| In-hospital need for NIV (non-invasive ventilation) within 24 hours | Day 30 from randomization | Use of non-invasive ventilation recorded within 24 hours of hospital admission, collected from the patient's electronic hospital medical record |
| In-hospital need for NIV within 7 days | Day 30 from randomization | Use of non-invasive ventilation recorded within 7 days of hospital admission, collected from the patient's electronic hospital medical record |
| In-hospital need for NIV within 30 days | Day 30 from randomization | Use of non-invasive ventilation recorded within 30 days of randomization, collected from the patient's electronic hospital medical record |
| Time to NIV | Day 30 from randomization | Time from hospital admission to initiation of non-invasive ventilation, collected from the patient's electronic hospital medical record |
| Mortality, 24-hour | 24 hours from randomization | Vital status assessed 24 hours after randomization using hospital electronic medical records |
| In-hospital need for invasive mechanical ventilation within 7 days | Day 30 from randomization | Initiation of invasive mechanical ventilation within 7 days of hospital admission, collected from the patient's electronic hospital medical record |
| In-hospital need for invasive mechanical ventilation within 30 days | Day 30 from randomization | Initiation of invasive mechanical ventilation within 30 days of randomization, collected from the patient's electronic hospital medical record |
| Time to invasive ventilation | Day 30 from randomization | Time from hospital admission to initiation of invasive mechanical ventilation, collected from the patient's electronic hospital medical record |
| Proportion of patients with respiratory acidosis on arrival to hospital | Day 30 from randomization | Presence of respiratory acidosis (PaCO₂ \>6.3 kPa and pH \<7.35) assessed via arterial blood gas analysis within 30 minutes after arrival, collected from the patient's electronic hospital medical record |
| The degree of acidosis based on the pH (potential of hydrogen) value | Day 30 from randomization | Lowest pH value measured from arterial blood gas within 30 minutes of hospital arrival, collected from the patient's electronic hospital medical record |
| Patient experienced dyspnoea on a verbal rating scale 0-10 | Day 30 from randomization | Patient-reported dyspnoea score at hospital arrival on a scale from 0 (no dyspnoea) to 10 (worst imaginable dyspnoea), collected from the prehospital patient record and hospital medical record |
| Readmission rate | Day 30 after discharge | Proportion of patients readmitted to hospital within 30 days after discharge from index hospitalization, collected from the patient's electronic hospital medical record |
| Time to readmission | Day 30 after discharge | Number of days from hospital discharge to first hospital readmission within 30 days, collected from the patient's electronic hospital medical record |
| In-hospital need for invasive mechanical ventilation within 24 hours | Day 30 from randomization | Initiation of invasive mechanical ventilation within 24 hours of hospital admission, collected from the patient's electronic hospital medical record |
Countries
Denmark
Contacts
Primary ContactMartin F Gude, PhD
Backup ContactArne Sylvester R Jensen
Outcome results
None listed