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
Protocol serial number HTA 01/43/01
Sponsor Department of Health (UK)
Funder NIHR Health Technology Assessment Programme - HTA (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronym3CPO
Study objectivesTo 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) studiedCardiovascular diseases: Heart disease
InterventionContinuous 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 typeOther
Primary outcome measure(s)

Added on the 12th June 2007:
1. NIV versus standard therapy: seven-day mortality
2. CPAP versus NIPPV: seven-day mortality or intubation

Key secondary outcome measure(s)

Added on the 12th June 2007:
1. Physiology
2. Side-effects including Myocardial Infacrtion (MI)
3. Cost-effectiveness

Completion date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration1200
Key inclusion criteria1. More than 16 years
2. Acute Cardiogenic Pulmonary Oedema (ACPO) principal clinical complaint
3. Confirmed diagnosis of ACPO
Key exclusion criteria1. Patients needing immediate life-saving interventions
2. Inability to provide informed consent
Date of first enrolment01/06/2003
Date of final enrolment30/04/2008

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Emergency Department
Edinburgh
EH16 4SA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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