Condition category
Respiratory
Date applied
15/06/2006
Date assigned
28/06/2006
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.papworthpeople.com

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

  1. 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.

Additional files

Editorial Notes