Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000487011
Ethics application status
Approved
Date submitted
9/06/2010
Date registered
11/06/2010
Date last updated
6/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehospital continuous positive airway pressure (CPAP) for acute cardiogenic pulmonary oedema: a randomised controlled trial.
Scientific title
In prehospital patients with acute cardiogenic pulmonary oedema, does continuous positive airway pressure (CPAP) plus standard care, compared to standard care alone, reduce mortality?
Secondary ID [1] 251996 0
Nil
Universal Trial Number (UTN)
Trial acronym
CPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute cardiogenic pulmonary oedema 257548 0
Condition category
Condition code
Cardiovascular 257442 257442 0 0
Other cardiovascular diseases
Respiratory 257443 257443 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard prehospital care plus continuous positive airway pressure (CPAP).

Standard care consists of sublingual glyceral trinitrate, intravenous frusemide, intranvenous morphine, and nebulised salbutamol. Patients may receive any combination of the above on a case by case basis. In addition the intervention group will receive continuous postitive airway pressure using the Boussignac CPAP device at a therapeutic level of 10cm H2O positive end expiratory pressure, a therapeutic goods association (TGA) approved lightweight and portable CPAP system. Patients randomised to this intervention group will begin receiving CPAP on scene administered by the paramedics. CPAP will be continuously administered until arrvial at the emergency department or until the patient's clinical condition warrants cessation of the CPAP therapy
Intervention code [1] 256454 0
Treatment: Devices
Comparator / control treatment
Standard prehospital care alone. Standard care consists of sublingual glyceral trinitrate, intravenous frusemide, intranvenous morphine, and nebulised salbutamol. Standard care will be initiated on scene following randomisation and allocation to that group. Standard care will continue to be administered according to ambulance service protocol until arrvial at the emergency department
Control group
Active

Outcomes
Primary outcome [1] 258607 0
In-hospital mortality. This will be assessed by a staff member of the research institute who will access the patient's hospital records. Ethical approval has been granted to access and source this information and reord it on a data colelction sheet.
Timepoint [1] 258607 0
From arrival in emergency department to a maximum in hospital follow up period of 30 days. Assessment of the outcome will occur within one week of this 30 day period concluding on a case by case basis.
Secondary outcome [1] 264154 0
Rate of intubation. This will be assessed by a staff member of the research institute who will access the patient's hospital records. Ethical approval has been granted to access and source this information and record it on a data collection sheet.
Timepoint [1] 264154 0
Prehospital and inhospital period up to 30 days, assessed within one week of the 30 day period concluding by a staff member of the research institute who will access the patient's hospital records. Ethical approval has been granted to access and source this information and record on a data colelction sheet.
Secondary outcome [2] 264501 0
Hospital admission rate. Assessed by a staff member of the research institute who will access the patient's hospital records. Ethical approval has been granted to access and source this information and record it on data collection sheet.
Timepoint [2] 264501 0
Assessed within one week of the 30 day period concluding by a staff member of the research institute who will access the patient's hospital records. Ethical approval has been granted to access and source this information.
Secondary outcome [3] 264502 0
Emergency department length of stay, measured in hours. This information will be measured from the time of arrival at the emergency department as taken from the ambulance dispatch system database.
Timepoint [3] 264502 0
At time of discharge from emergency department, or at time of admission to hospital or intensive care unit (ICU), Taken from the time of arrvial at the emergency department.

Eligibility
Key inclusion criteria
Inclusion criteria:
i. aged greater than or equal to 18 years
ii. conscious (Glasgow Coma Scale (GCS)=15)
iii. presumed diagnosis of acute cardiogenic pulmonary oedema with:
a) increased work of breathing/accessory muscle use
b) hypoxic with oxygen saturation less than 92%
c) bilateral basal crackles on chest auscultation
d) respiratory rate greater than or equal to 28
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. inadequate ventilatory effort requiring ventilatory assistance (ie. hypoventilation requiring intermittent positive pressure ventilation (IPPV))
ii. systolic blood pressure less than 100 mmHg
iii. suspected acute myocardial infarction

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)
Paramedics will randomise patients on scene after confirming eligibility using sealed numbered opaque envelopes containing allocation prepared centrally at the Ambulance Research Institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using blocks of varying sizes using a sequence created by a random number generating computer program
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
Suspended
Date of first participant enrolment
Anticipated
14/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257117 0
Commercial sector/Industry
Name [1] 257117 0
Proact Medical Systems (Device Technologies)
Country [1] 257117 0
Australia
Primary sponsor type
Government body
Name
Ambulance Research Institute, Ambulance Service of New South Wales
Address
Locked Bag 105
Rozelle NSW 2039
Country
Australia
Secondary sponsor category [1] 256377 0
None
Name [1] 256377 0
Address [1] 256377 0
Country [1] 256377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258948 0
Sydney South West Area Health Service (RPA Zone)
Ethics committee address [1] 258948 0
Level 3 Building 92
Royal Prince Alfred Hospital
Missenden Road,
Camperdown NSW 2050
Ethics committee country [1] 258948 0
Australia
Date submitted for ethics approval [1] 258948 0
Approval date [1] 258948 0
05/03/2010
Ethics approval number [1] 258948 0
X09-0270 & HREC/09/RPAH/453

Summary
Brief summary
Continous postitive airway pressure (CPAP) is a proven therapy when administered in the emergency department. The evidence supporting it's use in the preshospital setting is not definitive and consisits of surrogate outcome measures hence this trial, powered to detect a difference in the true outcome of mortality, should provide important evidence. Our hypothesis is that adding continous positive airway pressure to standard care in the prehospial setting will decrease hospital mortality comparted to standard care alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31128 0
Address 31128 0
Country 31128 0
Phone 31128 0
Fax 31128 0
Email 31128 0
Contact person for public queries
Name 14375 0
Paul Simpson
Address 14375 0
Locked Bag 105
Rozelle NSW 2039
Country 14375 0
Australia
Phone 14375 0
+61 2 9779 3850
Fax 14375 0
Email 14375 0
psimpson@ambulance.nsw.gov.au
Contact person for scientific queries
Name 5303 0
Dr Jason Bendall
Address 5303 0
Locked Bag 105
Rozelle NSW 2039
Country 5303 0
Australia
Phone 5303 0
+61 2 9779 3850
Fax 5303 0
Email 5303 0
jbendall@ambulance.nsw.gov.au

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
No additional documents have been identified.