COPD Exacerbation Clinical Trial
— STOP-COPDOfficial title:
Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
The goal of this clinical trial is to test titrated oxygen in prehospital patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The main question it aims to answer is: - To determine whether prehospital titrated oxygen strategy in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care. Participants in the intervention will receive titrated oxygen - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 (oxygen saturation) 88-92%. The intervention will be compared to standard treatment, using compressed oxygen (100%) as driver for inhaled bronchodilators.
Status | Not yet recruiting |
Enrollment | 1888 |
Est. completion date | March 30, 2028 |
Est. primary completion date | March 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Denmark Region |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality, 30-day | Day 30 from randomization | ||
Secondary | Mortality, 24-hour | Day 30 from randomization | ||
Secondary | Mortality, 7-day | Day 30 from randomization | ||
Secondary | Length of hospital stay | Day 30 from randomization | ||
Secondary | ICU admission rate | Day 30 from randomization | ||
Secondary | Length of ICU stay | Day 30 from randomization | ||
Secondary | In-hospital need for NIV (non-invasive ventilation) within 24 hours | Day 30 from randomization | ||
Secondary | In-hospital need for NIV within 7 days | Day 30 from randomization | ||
Secondary | In-hospital need for NIV within 30 days | Day 30 from randomization | ||
Secondary | Time to NIV | Day 30 from randomization | ||
Secondary | In-hospital need for invasive mechanical ventilation within 24 hours | Day 30 from randomization | ||
Secondary | In-hospital need for invasive mechanical ventilation within 7 days | Day 30 from randomization | ||
Secondary | In-hospital need for invasive mechanical ventilation within 30 days | Day 30 from randomization | ||
Secondary | Time to invasive ventilation | Day 30 from randomization | ||
Secondary | Proportion of patients with respiratory acidosis on arrival to hospital | Day 30 from randomization | ||
Secondary | The degree of acidosis based on the pH (potential of hydrogen) value | Day 30 from randomization | ||
Secondary | Patient experienced dyspnoea on a verbal rating scale 0-10 | Day 30 from randomization | ||
Secondary | Readmission rate | Day 30 after discharge | ||
Secondary | Time to readmission | Day 30 after discharge |
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