Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Leman

ORCID ID

Contact details

Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013101032

Study information

Scientific title

Acronym

Study hypothesis

This study will seek to determine whether the Boussignac valve system is as effective as conventional CPAP using a Drager CF800 circuit.

Ethics approval

Not provided 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

Respiratory: Acute pulmonary oedema

Intervention

The patient will be randomised to one of two groups:
1. CPAP with the closed circuit Drager CF800 system
OR
2. CPAP with the open circuit Vygon Boussignac valve system

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome measure will be the PaCO2 at 30 and 60 minutes. Other outcome measures will be PaO2 at 30 and 60 minutes, need for intubation, and tolerance of mask/circuit.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2001

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with acute pulmonary oedema attending Accident and Emergency (A&E). We intend to recruit 50 patients to allow for recruitment errors and drop outs etc.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2001

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Acute Medicine
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' NHS Trust (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15953223

Publication citations

  1. Results

    Leman P, Greene S, Whelan K, Legassick T, Simple lightweight disposable continuous positive airways pressure mask to effectively treat acute pulmonary oedema: randomized controlled trial., Emerg Med Australas, 2005, 17, 3, 224-230, doi: 10.1111/j.1742-6723.2005.00727.x.

Additional files

Editorial Notes