Randomised trial of outpatient versus inpatient initiation on non-invasive ventilation (NIV) in adults and children with chronic ventilatory failure

ISRCTN ISRCTN77271265
DOI https://doi.org/10.1186/ISRCTN77271265
Secondary identifying numbers N0201109246
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
25/10/2011
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 Anita K Simonds
Scientific

Respiratory Medicine
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom

Phone +44 (0)20 7351 8911
Email a.simonds@rbh.nthames.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesAim is to investigate whether starting NIV as an outpatient is as effective in terms of physiological improvement, tolerance and compliance, as standard inpatient initiation. We will also determine the cost and staffing implications of this change in clinical practice.
Ethics approval(s)Ethics approval was received from the local medical ethics committee before trial recruitment began.
Health condition(s) or problem(s) studiedRespiratory: Chronic ventilatory failure
Intervention24 patients fulfilling entry criteria will be randomised to outpatient or inpatient initiation of NIV using a block randomisation process to ensure balance for diagnosis and age.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date13/02/2002
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants24
Key inclusion criteria24 patients per year.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment13/02/2002
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Respiratory Medicine
London
SW3 6NP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Brompton and Harefield NHS Trust (UK)

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 01/11/2008 Yes No