Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr WJ Kinnear

ORCID ID

Contact details

c/o Dr Kinnear's Secretary
Respiratory Department
D Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 (41979)

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192095136

Study information

Scientific title

Acronym

Study hypothesis

Is there any measurable difference in outcome when using a nasal mask versus full-face mask when using bilevel non-invasive ventilation to treat patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) and hypercapnic respiratory failure?

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

Chronic obstructive pulmonary disease (COPD)

Intervention

Not provided at time of registration

17/09/2012: Please note that this trial was stopped due to a lack of funding

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improvement of arterial blood gases at 1 h and 4 h, the length of time patients spend on the ventilator in the first 24 h, the comfort of the patient (visual analogue scale) and the survival to discharge.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/01/2002

Overall trial end date

01/06/2003

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

Total number of subjects = 50.

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

15/01/2002

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Dr Kinnear's Secretary
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Queens Medical Centre University Hospital 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

Publication citations

Additional files

Editorial Notes