2022-500816-21-00
Withdrawn
Phase 4
STOP-COPD Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Præhospitalet1 site in 1 country1,888 target enrollmentStarted: September 12, 2022Last updated:
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Præhospitalet
- Enrollment
- 1,888
- Locations
- 1
- Primary Endpoint
- 30-day mortality
Overview
Brief Summary
To determine whether prehospital titrated oxygen in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Treating EMT or Paramedic suspects acute exacerbation of chronic obstructive pulmonary disease
- •Patients over the age of 40 years
Exclusion Criteria
- •Non-COPD bronchospasm
- •Known or suspected pregnancy
- •Prehospital NIV, invasive or bag mask assisted ventilation
- •Allergy to inhalation drug (Salbutamol)
- •Transfer between hospitals
- •More than 2 doses (5 mg salbutamol) inhalation drug, given by EMT or paramedic (acute treatment), before allocated treatment is initiated
- •Readmission within 30 days from last randomization
Outcomes
Primary Outcomes
30-day mortality
30-day mortality
Secondary Outcomes
- 24-hour mortality
- 7-day mortality
- Length of hospitalization
- ICU admission rate
- Length of ICU admission
- In-hospital need for non-invasive ventilation
- Time to non-invasive ventilation
- In-hospital need for invasive ventilation
- Time to invasive ventilation
- Proportion of patients with respiratory acidosis on arrival to hospital
- The degree of acidosis based on the pH-value
- Patient experienced dyspnoea on a verbal rating scale 0-10
- Readmission rate
Investigators
Martin Fauerholt Gude
Scientific
Præhospitalet
Study Sites (1)
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