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
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