None listed
Conditions
Brief summary
Oxygen has been routinely administered as part of the standard of care to patients presenting with acute myocardial infarction for many years. However, several reviews of the limited experimental and clinical evidence have questioned its’ benefits and risks. The NZ national cardiac clinical network trials group will compare two oxygen protocols as part of usual care in the ambulance, emergency department, coronary care unit and cardiac catheter laboratory. The proposed study is a ~2 year randomized cross-over study within the 4 regional cardiac networks. The primary outcome will be 30 day mortality.
Interventions
Intervention strategies will commence from first medical contact by the ambulance service or in the emergency department.
High oxygen strategy
In patients with probable or confirmed acute coronary syndrome give oxygen for ischemic chest pain, ischemic ECG changes or dyspnea related to myocardial ischemia irrespective of the measured oxygen saturation level.
In the ambulance oxygen will be administered by face mask at ~8l/minute. If a face mask is not tolerated give oxygen by nasal prongs at ~
Intervention strategies will commence from first medical contact by the ambulance service or in the emergency department. High oxygen strategy In patients with probable or confirmed acute coronary syndrome give oxygen for ischemic chest pain, ischemic ECG changes or dyspnea related to myocardial ischemia irrespective of the measured oxygen saturation level. In the ambulance oxygen will be administered by face mask at ~8l/minute. If a face mask is not tolerated give oxygen by nasal prongs at ~4 l/minute. Oxygen flow rate is increased if necessary to achieve saturation greater than or equal to 95%. Continue oxygen until the patient is admitted to hospital or when a doctor decides it is no longer necessary. In hospital oxygen can be administered by face mask at between 5 and 8 l/minute or by nasal prongs between 1 and 4 L/minute. Increase or adjust the flow rate to achieve an oxygen saturation between 95% and 99%. The treating clinician will decide on oxygen flow rate, method of administration, and when to discontinue oxygen when symptoms and signs (including ECG changes) of ischemia have resolved, or when clinically appropriate. Caution or avoid high flow oxygen in patients at risk of hypercapnia, including those with possible obesity hypoventilation syndrome or chronic obstructive pulmonary disease. In individual cases the oxygen protocol can be overruled by clinician preference or clinical indication. Two regions will be randomised to use the high oxygen strategy for 4 months, then wash out for two weeks, then use the conservative oyygen strategy for 12 months, then wash-out for two weeks, then use the high oxygen strategy for 8 months.
Sponsors
Dr Ralph Stewart
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients in New Zealand admitted to the coronary care unit and/or cardiac catheter laboratory with an acute coronary syndrome (ACS) at participating hospitals. 2. Patients attended by the ambulance service with a confirmed ACS who die before admission to CCU or catheter lab.
Exclusion criteria
1. Dead on ambulance arrival at the scene 2. Presented with an out of hospital cardiac arrest 3. Ventilated prior to admission to CCU/catheter lab 4. Documented for end of life cares 5. On home oxygen 6. Not admitted to CCU or catheter lab because of advanced age, co-morbidity, or because a diagnosis other than ACS is made. (this does not exclude patient from administered oxygen strategy prior to this decision being made).
Outcome results
None listed