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Trial registered on ANZCTR


Registration number
ACTRN12609000410257
Ethics application status
Approved
Date submitted
9/05/2009
Date registered
3/06/2009
Date last updated
9/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized clinical trial of continuous positive airway pressure (CPAP) in the treatment of acute cardiogenic pulmonary oedema (APO) patients in the pre-hospital setting
Scientific title
A randomized clinical trial assessing survival rates in patients with acute cardiogenic pulmonary oedema (ACPO) who are treated with continuous positive airway pressure (CPAP) in the pre-hospital setting
Secondary ID [1] 262846 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Cardiogenic Pulmonary Oedema 4745 0
Condition category
Condition code
Cardiovascular 237080 237080 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous postive airway pressure (CPAP) at 10 cm H20 with face mask will be used for patients in acute respiratory distress with clnical diagnosis of acute cardiogenic pulmonary oedema) ACPO. The duration of the treatment will be time transported and treated by paramedics. All other treatments will be cosistant between groups (Glycerine trinitrate (GTN) spray incremental doses every 5 min of 400 mcg up to 1600 mcg sublingual with repreated 1600 mcg every 5 min as long as BP >100 systolic, Frusemide dose 40 mg increments every 20 min to max 80 mg intravenous)
Intervention code [1] 4520 0
Treatment: Devices
Comparator / control treatment
inspired positive pressure ventilation (IPPV) with bag valve mask will be used for patients in acute respiratory distress with clnical diagnosis of acute cardiogenic pulmonary oedema) ACPO. The duration of the treatment will be time transported and treated by paramedics. All other treatments will be cosistant between groups (GTN, Frusemide)
Control group
Active

Outcomes
Primary outcome [1] 5916 0
Mortality
Timepoint [1] 5916 0
During this admission and treatement episode
Secondary outcome [1] 241975 0
requirement for invasive ventilation (Endotracheal tube) - Patient who do not support there airways and have a reducing level of consciousness may require invasive ventilation this will be a clincial judgement by the paramedics.
Timepoint [1] 241975 0
During this admission and treatment episode
Secondary outcome [2] 241976 0
Arterial blood gas (Partial pressure oxygen (PO2), Partial pressure carbon dioxide (pCO2), Bicarbonate, pH)
Timepoint [2] 241976 0
within 30 min upon arrival to hospital and no other assessment of blood gases will be reviewed as the pre-hosptial treatment has ceased.
Secondary outcome [3] 241977 0
requirement for Iintesive care unit (ICU) admisson
Timepoint [3] 241977 0
During this admission and treatment episode
Secondary outcome [4] 241978 0
Vital signs (Blood Pressure (BP), Respiratory Rate - clinically by paramedics, Oxygen Saturation - portable machine pulse oximetry, Heart rate, Glascow coma scale (GCS)
Timepoint [4] 241978 0
During this admission and treatment episode (continuously for saturations and at the discretion of the paramedics for the other outcomes)

Eligibility
Key inclusion criteria
Age over 18 years
Crackles on auscultation of the lungs
Breathlessness and increased work of breathing
History of ischemic heart disease (IHD) or risk factor contributing to IHD
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other respiratory conditions (particularly asthma and Chronic obstructive pulmonary disease (COPD)

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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4925 0
Commercial sector/Industry
Name [1] 4925 0
Fisher and paykel Healthcare
Address [1] 4925 0
PO Box 167
36-40 New Street
Ringwood VIC 3134
Country [1] 4925 0
Australia
Funding source category [2] 288103 0
University
Name [2] 288103 0
The NHMRC Centre of Research Excellence (CRE) University of Tasmania, Australia
Address [2] 288103 0
Menzies Research Institute Tasmania, University of Tasmania, Private Bag 23 Hobart, Tasmania Australia 7001
Country [2] 288103 0
Australia
Primary sponsor type
Government body
Name
Tasmanian Ambulance Service department of health and human services
Address
1 Melville street
Hobart TAS 7000
Country
Australia
Secondary sponsor category [1] 4454 0
Commercial sector/Industry
Name [1] 4454 0
Fisher and Paykel Healthcare
Address [1] 4454 0
PO Box 167
36-40 New Street
Ringwood VIC 3134
Country [1] 4454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6998 0
National Ethics Application Form (NEAF)- Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 6998 0
Human Research Ethics Committee Administration
University of Tasmania
Office of Research Services
Private Bag 01
Hobart Tasmania 7001
Ethics committee country [1] 6998 0
Australia
Date submitted for ethics approval [1] 6998 0
Approval date [1] 6998 0
14/11/2008
Ethics approval number [1] 6998 0

Summary
Brief summary
Purpose of trial is to compare Continuous positive airway pressure (CPAP) versus conventional therapy of inspired postive pressure ventilation with bag valve mask.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29588 0
Dr Michael Austin
Address 29588 0
Menzies Research Institute Tasmania, University of Tasmania, Private Bag 23 Hobart, Tasmania Australia 7001
Country 29588 0
Australia
Phone 29588 0
61 3 6226 7757
Fax 29588 0
Email 29588 0
maaustin@utas.edu.au
Contact person for public queries
Name 12835 0
Dr Dr Michael Austin
Address 12835 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 12835 0
Australia
Phone 12835 0
61 3 6226 7757
Fax 12835 0
Email 12835 0
maaustin@utas.edu.au
Contact person for scientific queries
Name 3763 0
Dr Dr Michael Austin
Address 3763 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 3763 0
Australia
Phone 3763 0
61 3 6226 7757
Fax 3763 0
Email 3763 0
maaustin@utas.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary