A randomized controlled trial comparing controlled oxygen therapy versus high flow oxygen therapy for acute myocardial infarctions in the pre-hospital setting

A randomized controlled trial assessing resolution of chest pain in patients with acute myocardial infarction who are treated with controlled oxygen therapy versus high flow oxygen therapy in the pre-hospital setting

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000466246

Enrollment

200

Registered

2009-06-16

Start date

2012-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will advance our understanding of the appropriate management of patients suffering AMI by quantifying the ability of controlled oxygen therapy to reduce adverse outcomes. Our findings will inform the development of guidelines for the local and international use of oxygen therapy in the treatment of AMI, with the potential to modify current practice. The findings of this study with directly benefit the Tasmanian community by improving health outcomes for AMI patients and reducing the overall burden of coronary heart disease in Tasmania.

Interventions

Intervention: controlled oxygen therapy to maintain oxygen saturations between 92-96% Control: 8-15 L/min oxygen via non-rebreather mask Time frame: for the duration of the ambulance transport to hospital

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The study population will be patients attended by the Tasmanian Ambulance Service in the Launceston region with a complaint of non-traumatic chest pain and clinical features and history consistent with acute coronary syndrome and coronary heart disease (CHD). Cases will be considered for inclusion if they meet the following criteria: 1. Age over 18 years; and 2. Complaint of chest pain, pressure or tightness; and/or 3. Risk factor of acute coronary syndrome and CHD (include: hypertension, diabetes, dyslipodemia, age, sex, family history, smoking history and history of CHD); and/or 4. Ischaemic changes on electrocardiogram (ECG); and 5. Transported to the Launceston General Hospital by Tasmanian Ambulance Service. Eligible cases will be further defined by diagnosis of AMI, made by independent cardiologists, based on patient records (ECG and history), lab results (troponin, creatinine kinase (CK)) and/or evidence from coronary angiography.

Exclusion criteria

Cases will be excluded if no recordings of oxygen saturations are available.

Outcome results