Contact information
Type
Scientific
Primary contact
Dr Mark Elliott
ORCID ID
Contact details
St James' University Hospital
Department of Respiratory Medicine
Ward 14
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 6037
mark.elliott@lineone.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H0020 ELLIOTT R&D
Study information
Scientific title
Acronym
Study hypothesis
Acute exacerbations of COPD are a common reason for hospital admission and are a cause of significant mortality. Non-invasive ventilation (NIV) via a face or nasal mask has been shown to reduce mortality and the need for intubation. However the studies have been carried out in units with a particular expertise in the techniques involved. Instituting NIV in a distressed, dispnoeic individual and matching the ventilator to the patients requirements is difficult. The early introduction of NIV is easier (the patient is better able to cooperate and lower, more comfortable inflation pressures can be used) and may interrupt a vicious cycle of deterioration before it is well established. Moreover simpler ventilations, which do not require great expertise and are therefore practical for use in non-specialist units, can be used. We wish to establish whether early NIV can be widely applied, with benefit, in a variety of hospitals.
Ethics approval
Not provided at time of registration
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Respiratory tract diseases: Chronic obstructive pulmonary disease
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/12/1996
Overall trial end date
31/12/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/12/1996
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James' University Hospital
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
2003 cost effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/12727767
Publication citations
-
Cost effectiveness results
Plant PK, Owen JL, Parrott S, Elliott MW, Cost effectiveness of ward based non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease: economic analysis of randomised controlled trial., BMJ, 2003, 326, 7396, 956, doi: 10.1136/bmj.326.7396.956.