Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
STOP-COPD
2 other identifiers
interventional
1,888
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
June 10, 2025
June 1, 2025
2 years
January 10, 2023
June 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality, 30-day
Vital status assessed 30 days after randomization using hospital electronic medical records
Day 30 from randomization
Secondary Outcomes (18)
Mortality, 24-hour
24 hours from randomization
Mortality, 7-day
Day 7 from randomization
Length of hospital stay
Day 30 from randomization
ICU admission rate
Day 30 from randomization
Length of ICU stay
Day 30 from randomization
- +13 more secondary outcomes
Study Arms (2)
Titrated Oxygen
EXPERIMENTALIf 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.
Standard Oxygen
ACTIVE COMPARATORIf 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients over the age of 40
- EMT or Paramedic suspected AECOPD
- Confirmed suspicion of COPD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prehospital Emergency Medical Servises, Central Denmark Region
Aarhus N, 8200, Denmark
Related Publications (1)
Jensen ASR, Valentin JB, Mulvad MG, Hagenau V, Skaarup SH, Johnsen SP, Vaeggemose U, Gude MF. Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial. Trials. 2024 Jan 25;25(1):85. doi: 10.1186/s13063-024-07920-5.
PMID: 38273393DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin F Gude, PhD
Central Denmark Region
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2023
First Posted
January 30, 2023
Study Start
June 2, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 9 months after primary results publication; data will remain available until de-identified data are no longer stored according to ICMJE recommendations and EU regulations.
- Access Criteria
- Researchers must submit a methodologically sound proposal for use of the data. Access will be granted following review and approval by the local trial administration. A data-sharing agreement will be required.
De-identified individual participant data (IPD) will be made available to researchers whose proposed use of the data has been approved by the local administration. Data will be shared starting 9 months after publication of the primary results and will be accessible until data are no longer stored, according to current ICMJE recommendations and EU data protection regulations. All trial-related documents (e.g., protocol, statistical analysis plan) will be made publicly available on the trial website. Patient-related data will not be accessible on the website.