RecruitingPhase 4NCT05703919

Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease


Sponsor

Central Denmark Region

Enrollment

1,888 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Inclusion Criteria3

  • Patients over the age of 40
  • EMT or Paramedic suspected AECOPD
  • Confirmed suspicion of COPD

Exclusion Criteria7

  • 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

Interventions

DRUGTitrated Oxygen

Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%

DRUGStandard Oxygen

Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators


Locations(1)

Prehospital Emergency Medical Servises, Central Denmark Region

Aarhus N, Denmark

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NCT05703919


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