Clinical trial NCT05703919: Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Official title: Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: COPD Exacerbation
COPD Exacerbation Acute
Keywords: Titrated Oxygen
COPD Exacerbation
Prehospital
COPD
Lead sponsor: Central Denmark Region
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 1888
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mortality, 30-day
timeFrame: Day 30 from randomization
Secondary outcomes:
measure: Mortality, 24-hour
timeFrame: 24 hours from randomization
measure: Mortality, 7-day
timeFrame: Day 7 from randomization
measure: Length of hospital stay
timeFrame: Day 30 from randomization
measure: ICU admission rate
timeFrame: Day 30 from randomization
measure: Length of ICU stay
timeFrame: Day 30 from randomization
measure: In-hospital need for NIV (non-invasive ventilation) within 24 hours
timeFrame: Day 30 from randomization
measure: In-hospital need for NIV within 7 days
timeFrame: Day 30 from randomization
measure: In-hospital need for NIV within 30 days
timeFrame: Day 30 from randomization
measure: Time to NIV
timeFrame: Day 30 from randomization
measure: In-hospital need for invasive mechanical ventilation within 24 hours
timeFrame: Day 30 from randomization
measure: In-hospital need for invasive mechanical ventilation within 7 days
timeFrame: Day 30 from randomization
measure: In-hospital need for invasive mechanical ventilation within 30 days
timeFrame: Day 30 from randomization
measure: Time to invasive ventilation
timeFrame: Day 30 from randomization
measure: Proportion of patients with respiratory acidosis on arrival to hospital
timeFrame: Day 30 from randomization
measure: The degree of acidosis based on the pH (potential of hydrogen) value
timeFrame: Day 30 from randomization
measure: Patient experienced dyspnoea on a verbal rating scale 0-10
timeFrame: Day 30 from randomization
measure: Readmission rate
timeFrame: Day 30 after discharge
measure: Time to readmission
timeFrame: Day 30 after discharge
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Servises, Central Denmark Region
Study officials:
affiliation: Central Denmark Region
name: Martin F Gude, PhD
role: PRINCIPAL_INVESTIGATOR
References: