Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
25/10/2011
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 Anita K Simonds

ORCID ID

Contact details

Respiratory Medicine
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8911
a.simonds@rbh.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201109246

Study information

Scientific title

Acronym

Study hypothesis

Aim 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

Ethics approval was received from the local medical ethics committee before trial recruitment began.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory: Chronic ventilatory failure

Intervention

24 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 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

13/02/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

24 patients per year.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

13/02/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Royal Brompton and Harefield NHS Trust (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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18774702

Publication citations

  1. Results

    Chatwin M, Nickol AH, Morrell MJ, Polkey MI, Simonds AK, Randomised trial of inpatient versus outpatient initiation of home mechanical ventilation in patients with nocturnal hypoventilation., Respir Med, 2008, 102, 11, 1528-1535, doi: 10.1016/j.rmed.2008.07.019.

Additional files

Editorial Notes