Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorCentral Denmark Region
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients over the age of 40
EMT or Paramedic suspected AECOPD
Confirmed suspicion of COPD
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Titrated Oxygen
DrugTitrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
Standard Oxygen
DrugStandard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Treatment groups
1,888 Participants
are divided into 2 treatment groupsGroup A: Titrated OxygenExperimental treatment 1 intervention
Group B: Standard OxygenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mortality, 30-day
Vital status assessed 30 days after randomization using hospital electronic medical records
Time frame
Day 30 from randomizationSecondary outcomes
1
Mortality, 24-hour
Vital status assessed 24 hours after randomization using hospital electronic medical records
Time frame
24 hours from randomization2
Mortality, 7-day
Vital status assessed 7 days after randomization using hospital electronic medical records
Time frame
Day 7 from randomization3
Length of hospital stay
Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records
Time frame
Day 30 from randomization4
ICU admission rate
Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record
Time frame
Day 30 from randomizationSponsors and contacts
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Source ClinicalTrials.gov