Contact information
Type
Scientific
Primary contact
Dr N Oscroft
ORCID ID
Contact details
Papworth Hospital
Papworth Everard
CB3 8RE
United Kingdom
+44 (0)1480 830541
nick.oscroft@papworth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P01032; National Research Register: N0542167931
Study information
Scientific title
Acronym
Study hypothesis
Auto variable positive pressure ventilation is as efficiacious as standard positve pressure ventilation
Ethics approval
Huntingdon research ethics committee on 27/10/2005 (ref: 05/Q0104/118)
Study design
Randomised cross over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
There are two groups: the first will receive either auto variable positive airway pressure ventilation (auto VPAP) and the second group will receive standard non-invasive positive pressure ventilation (NIPPV). After eight weeks the two groups will cross over. The patients will be randomised to start on either auto VPAP or NIPPV. The control group is the group receiving standard NIPPV.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Nocturnal oxygenation
Secondary outcome measures
Pulmonary function
Overall trial start date
16/12/2005
Overall trial end date
01/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
2. Forced expiratory volume in one second (FEV1) < 50%
3. Smoking history > 20 pack years
4. Hypercapnic ventilatory failure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Age > 80
2. Body Mass Index (BMI) > 40
Recruitment start date
16/12/2005
Recruitment end date
01/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Papworth Hospital
Papworth Everard
CB3 8RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital Foundation NHS Trust (UK)
Sponsor details
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
+44 (0)1480 364448
alison.wooster@papworth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
ResMed
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21166627
Publication citations
-
Results
Oscroft NS, Ali M, Gulati A, Davies MG, Quinnell TG, Shneerson JM, Smith IE, A randomised crossover trial comparing volume assured and pressure preset noninvasive ventilation in stable hypercapnic COPD., COPD, 2010, 7, 6, 398-403, doi: 10.3109/15412555.2010.528084.