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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,888
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Prehospital Emergency Medical Servises, Central Denmark Region
Aarhus N, Denmark
RECRUITINGMortality, 30-day
Vital status assessed 30 days after randomization using hospital electronic medical records
Time frame: Day 30 from randomization
Mortality, 24-hour
Vital status assessed 24 hours after randomization using hospital electronic medical records
Time frame: 24 hours from randomization
Mortality, 7-day
Vital status assessed 7 days after randomization using hospital electronic medical records
Time frame: Day 7 from randomization
Length of hospital stay
Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records
Time frame: Day 30 from randomization
ICU admission rate
Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record
Time frame: Day 30 from randomization
Length of ICU stay
Number of days spent in the intensive care unit during the index hospitalization, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for NIV (non-invasive ventilation) within 24 hours
Use of non-invasive ventilation recorded within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for NIV within 7 days
Use of non-invasive ventilation recorded within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for NIV within 30 days
Use of non-invasive ventilation recorded within 30 days of randomization, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
Time to NIV
Time from hospital admission to initiation of non-invasive ventilation, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 24 hours
Initiation of invasive mechanical ventilation within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 7 days
Initiation of invasive mechanical ventilation within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 30 days
Initiation of invasive mechanical ventilation within 30 days of randomization, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
Time to invasive ventilation
Time from hospital admission to initiation of invasive mechanical ventilation, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
Proportion of patients with respiratory acidosis on arrival to hospital
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
Time frame: Day 30 from randomization
The degree of acidosis based on the pH (potential of hydrogen) value
Lowest pH value measured from arterial blood gas within 30 minutes of hospital arrival, collected from the patient's electronic hospital medical record
Time frame: Day 30 from randomization
Patient experienced dyspnoea on a verbal rating scale 0-10
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
Time frame: Day 30 from randomization
Readmission rate
Proportion of patients readmitted to hospital within 30 days after discharge from index hospitalization, collected from the patient's electronic hospital medical record
Time frame: Day 30 after discharge
Time to readmission
Number of days from hospital discharge to first hospital readmission within 30 days, collected from the patient's electronic hospital medical record
Time frame: Day 30 after discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.