Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease (STOP-COPD)

Central Denmark Region

Status and phase: Enrolling; Phase 4

Conditions: COPD Exacerbation Acute; COPD Exacerbation

Treatments: Drug: Standard Oxygen; Drug: Titrated Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05703919

5925 (Other Identifier)

2022-502003-30-00 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,888 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,888 participants in 2 patient groups

Titrated Oxygen

Experimental group

Description:

If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures). Following scenarios regarding SpO2 can occur during treatment: SpO2 \<88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter. SpO2 88-92%: No intervention. SpO2 \>92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.

Treatment:

Drug: Titrated Oxygen

Standard Oxygen

Active Comparator group

Description:

If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP. Following scenarios regarding SpO2 can occur during treatment: SpO2 \<88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min. SpO2 88-92%: No intervention. SpO2 \>92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.

Treatment:

Drug: Standard Oxygen