The STOP-COPD trial investigates the effect of titrated oxygen therapy in prehospital patients with suspected acute exacerbation of chronic obstructive pulmonary disease. The trial targets all patients with suspected acute exacerbation of chronic obstructive pulmonary disease requiring ambulance transport and inhalation therapy. The primary objective is to improve 30-day mortality for patients experiencing acute exacerbation of chronic obstructive pulmonary disease. 1,888 participants will be randomised in a 1:1 ratio, to receive either titrated oxygen or standard oxygen as a driver for nebulisation of inhaled medication throughout prehospital transport. The trial has been approved as a prehospital, randomised controlled, low-intervention, emergency trial by the National Ethics Committee and the Danish Medicines Agency.
Inclusion criteria
1.
Patients over the age of 40 years
2.
The treating emergency medical service (EMS) provider (emergency medical technician (EMT) or paramedic) suspects acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
3.
Confirmation of the EMS provider’s suspicion of chronic obstructive pulmonary disease (COPD)
4.
Need of inhaled bronchodilators
Exclusion criteria
1.
Non-chronic obstructive pulmonary disease (COPD) bronchospasm
2.
Known or suspected pregnancy
3.
Prehospital non-invasive ventilation (NIV), invasive ventilation or bag-mask-assisted ventilation
4.
Allergy to inhalation drug (Salbutamol)
5.
Transfer between hospitals
6.
Acute treatment by EMS providers with more than two doses (5 mg salbutamol) of inhalation drug before randomisation
7.
Readmission within 30 days from a previous randomisation
8.
Suspicion of acute coronary syndrome (ACS)
9.
Prior decline to participate in the trial
