A randomised controlled trial to compare auto variable positive airway pressure ventilation with conventional non-invasive positive pressure ventilation in the treatment of hypercapnic ventilatory failure in chronic obstructive pulmonary disease

ISRCTN ISRCTN91892415
DOI https://doi.org/10.1186/ISRCTN91892415
Secondary identifying numbers P01032; National Research Register: N0542167931
Submission date
15/06/2006
Registration date
28/06/2006
Last edited
03/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N Oscroft
Scientific

Papworth Hospital
Papworth Everard
CB3 8RE
United Kingdom

Phone +44 (0)1480 830541
Email nick.oscroft@papworth.nhs.uk

Study information

Study designRandomised cross over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesAuto variable positive pressure ventilation is as efficiacious as standard positve pressure ventilation
Ethics approval(s)Huntingdon research ethics committee on 27/10/2005 (ref: 05/Q0104/118)
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionThere 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 typeOther
Primary outcome measureNocturnal oxygenation
Secondary outcome measuresPulmonary function
Overall study start date16/12/2005
Completion date01/02/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. Age > 80
2. Body Mass Index (BMI) > 40
Date of first enrolment16/12/2005
Date of final enrolment01/02/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Papworth Hospital
Papworth Everard
CB3 8RE
United Kingdom

Sponsor information

Papworth Hospital Foundation NHS Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

Phone +44 (0)1480 364448
Email alison.wooster@papworth.nhs.uk
Website http://www.papworthpeople.com
ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Industry

ResMed

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2010 Yes No