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Recruiting
NCT05703919
Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Conditions: COPD Exacerbation, COPD Exacerbation Acute
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 1888
Sponsor: Central Denmark Region
Location: Prehospital Emergency Medical Servises, Central Denmark Region Aarhus N
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 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
Source: ClinicalTrials.gov (NCT05703919). StuddyBuddy aggregates publicly available trial information.