Oxygen Therapy in Acute Coronary Syndromes Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000461493
• Date of registration: 08/04/2016
• Prospective Registration: Yes
• Primary sponsor: Dr Ralph Stewart
• Public title: Oxygen Therapy in Acute Coronary Syndromes Trial
• Scientific title: All New Zealand Acute Coronary syndromes quality improvement (ANZACS-QI) registry trial to evaluate two oxygen protocols as part of usual care in patients presenting with a suspected acute coronary syndrome
• Date of first enrolment: 11/04/2016
• Target sample size: 21000
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616000461493.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy;

Countries of recruitment

New Zealand

Contacts

• Name: Dr Ralph Stewart

• Name: Dr Ralph Stewart

Key inclusion & exclusion criteria

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).


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome;
Acute Coronary Syndrome

Cardiovascular - Coronary heart disease

Intervention(s)

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.

Primary Outcome(s)

30 day mortality rate by electronic linkage to national mortality data-base[Mortality rate 30 days following episode of ACS]

Secondary Outcome(s)

Hospital readmission for cardiovascular cause at one year form national hosptial admission data.[One year following episode of ACS]

One year mortality rate
by electronic linkage to national mortality data-base[One year following episode of ACS]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Heart Foundation New Zealand

Ethics review

Status: Approved
Approval date:
Contact:

Health and Disability Ethics Committee