Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000466246
Ethics application status
Approved
Date submitted
4/06/2009
Date registered
16/06/2009
Date last updated
16/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial comparing controlled oxygen therapy versus high flow oxygen therapy for acute myocardial infarctions in the pre-hospital setting
Scientific title
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
Secondary ID [1] 262848 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 236925 0
Condition category
Condition code
Cardiovascular 237285 237285 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 236716 0
Treatment: Other
Comparator / control treatment
High Flow oxygen therapy- provide high concentration of oxygen 8-15 L/min by Non re-breather mask for the duration of the transport by ambulance.
Control group
Active

Outcomes
Primary outcome [1] 238096 0
Mortality, death in hospital post treatment by ambulance offerers for acute exacerbation of chronic obstructive pulmonary disease (AECOPD), or death during the care of ambulance officers
Timepoint [1] 238096 0
Death during treatment of patient by paramedics or during hospital stay after transport by ambulance and treated for an acute myocardial infarction (AMI), during this episode only
Secondary outcome [1] 242298 0
Time to resolution of chest pain this will be assessed during the transport and treatement of the patient. The paramedics will assess by asking the patient to rate their pain on a scale of 0-10 and it will be recorded in the electronic reporting system.
Timepoint [1] 242298 0
Time to resolution of chest pain after intitation of treatment and transport by ambulance for an acute myocardial infarction (AMI), during this episode only
Secondary outcome [2] 242299 0
Length of Hospital Stay
Timepoint [2] 242299 0
after treatment for AMI by ambulance officers the length of hospital stay during this admission measured in days
Secondary outcome [3] 242300 0
"vital signs" Blood pressure, respiratory rate, heart rate, oxygen saturation. The values will be taken by paramedics and recorded into the electronic reporting system
Timepoint [3] 242300 0
after treatment for AMI during transport to hospital monitoring vital signs every 10-15 minutes and measured for the duration of care by ambulance officers. Monitoring will stop once the patient has been handed over to the Emergency Department staff.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases will be excluded if no recordings of oxygen saturations are available.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random concealed evelopes containing cards with treatement allocation which will be drawn after assessment of patient and decided they meet the inclusion criteria
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237106 0
Charities/Societies/Foundations
Name [1] 237106 0
Clifford Craig Medical Research Trust
Country [1] 237106 0
Australia
Funding source category [2] 269667 0
Self funded/Unfunded
Name [2] 269667 0
Country [2] 269667 0
Primary sponsor type
University
Name
Menizes Research Institute
Address
Menzies Research Institute Private Bag 23, Hobart, TAS
7001
Country
Australia
Secondary sponsor category [1] 4607 0
None
Name [1] 4607 0
Address [1] 4607 0
Country [1] 4607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239205 0
National Ethics Application Form (NEAF)- Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 239205 0
Human Research Ethics Committee Administration University of Tasmania Office of Research Services Private Bag 01 Hobart Tasmania 7001
Ethics committee country [1] 239205 0
Australia
Date submitted for ethics approval [1] 239205 0
15/06/2009
Approval date [1] 239205 0
Ethics approval number [1] 239205 0
Ethics committee name [2] 239242 0
Ethics committee address [2] 239242 0
Ethics committee country [2] 239242 0
Date submitted for ethics approval [2] 239242 0
09/06/2009
Approval date [2] 239242 0
Ethics approval number [2] 239242 0
H0010676

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29705 0
Address 29705 0
Country 29705 0
Phone 29705 0
Fax 29705 0
Email 29705 0
Contact person for public queries
Name 12952 0
Dr Michael Austin
Address 12952 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 12952 0
Australia
Phone 12952 0
61 3 6226 7757
Fax 12952 0
Email 12952 0
[email protected]
Contact person for scientific queries
Name 3880 0
Dr Michael Austin
Address 3880 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 3880 0
Australia
Phone 3880 0
+61 404667762
Fax 3880 0
Email 3880 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOxygen therapy for acute myocardial infarction.2016https://dx.doi.org/10.1002/14651858.CD007160.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.