Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

  2. 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.

  3. 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.

Editorial Notes