Contact information
Type
Scientific
Primary contact
Dr Alasdair James Gray
ORCID ID
Contact details
Emergency Department
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
School of Health and Related Research
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 1334
alasdair.gray@luht.scot.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/43/01
Study information
Scientific title
Acronym
3CPO
Study hypothesis
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
Not requested at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/06/2003
Overall trial end date
30/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. More than 16 years
2. Acute Cardiogenic Pulmonary Oedema (ACPO) principal clinical complaint
3. Confirmed diagnosis of ACPO
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1200 (this information was added on the 12th June 2007)
Participant exclusion criteria
1. Patients needing immediate life-saving interventions
2. Inability to provide informed consent
Recruitment start date
01/06/2003
Recruitment end date
30/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Emergency Department
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18614781
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19615296
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20511258
Publication citations
-
Results
Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J, , Noninvasive ventilation in acute cardiogenic pulmonary edema., N. Engl. J. Med., 2008, 359, 2, 142-151, doi: 10.1056/NEJMoa0707992.
-
Results
Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, Crane S, Elliott M, Nicholl J, , A multicentre randomised controlled trial of the use of continuous positive airway pressure and non-invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial., Health Technol Assess, 2009, 13, 33, 1-106, doi: 10.3310/hta13330.
-
Results
Gray A, Goodacre S, Seah M, Tilley S, Diuretic, opiate and nitrate use in severe acidotic acute cardiogenic pulmonary oedema: analysis from the 3CPO trial., QJM, 2010, 103, 8, 573-581, doi: 10.1093/qjmed/hcq077.