Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Patients over the age of 40
• EMT or Paramedic suspected AECOPD
• Confirmed suspicion of COPD
Locations
Other Locations
Denmark
Prehospital Emergency Medical Servises, Central Denmark Region
RECRUITING
Aarhus N
Contact Information
Primary
Martin F Gude, PhD
martgude@rm.dk
0045 25343621
Backup
Arne Sylvester R Jensen
arjens@rm.dk
22396968
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 1888
Treatments
Experimental: Titrated Oxygen
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.
Active_comparator: Standard Oxygen
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.
Related Therapeutic Areas
Sponsors
Leads: Central Denmark Region