The effect of continuous positive airway pressure (CPAP) and non-invasive positive pressure ventilation (NIPPV) in acute cardiogenic pulmonary oedema (ACPO)

ISRCTN	ISRCTN07448447
DOI	https://doi.org/10.1186/ISRCTN07448447
Secondary identifying numbers	HTA 01/43/01

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 02/08/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alasdair James Gray
Scientific

Emergency Department
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
School of Health and Related Research
Edinburgh
EH16 4SA
United Kingdom

Phone	+44 (0)131 242 1334
Email	alasdair.gray@luht.scot.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	3CPO
Study objectives	To assess the clinical effectiveness of non-invasive ventilation against standard therapy alone More details can be found at http://www.hta.ac.uk/project/1338 Protocol can be found at http://www.hta.ac.uk/protocols/200100430001.pdf
Ethics approval(s)	Not requested at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Heart disease
Intervention	Continuous Positive Airway Pressure (CPAP) versus Non-Invasive Positive Pressure Ventilation (NIPPV) Please note that, as of 28 January 2008, the anticipated end date of this trial was updated from 31 December 2007 to 30 April 2008. Please note that as of 12th June 2007, the anticipated end date of this trial was extended to 31st December 2007 (Anticipated end date provided at time of registration: 30 June 2006). Recruitment to this trial was closed on 30 April 2007.
Intervention type	Other
Primary outcome measure	Added on the 12th June 2007: 1. NIV versus standard therapy: seven-day mortality 2. CPAP versus NIPPV: seven-day mortality or intubation
Secondary outcome measures	Added on the 12th June 2007: 1. Physiology 2. Side-effects including Myocardial Infacrtion (MI) 3. Cost-effectiveness
Overall study start date	01/06/2003
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	1200 (this information was added on the 12th June 2007)
Key inclusion criteria	1. More than 16 years 2. Acute Cardiogenic Pulmonary Oedema (ACPO) principal clinical complaint 3. Confirmed diagnosis of ACPO
Key exclusion criteria	1. Patients needing immediate life-saving interventions 2. Inability to provide informed consent
Date of first enrolment	01/06/2003
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Emergency Department

Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	10/07/2008	Yes	No
Results article	results	01/07/2009	Yes	No
Results article	results	01/08/2010	Yes	No