Condition category
Respiratory
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/07/2009
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 Justin Tuggey

ORCID ID

Contact details

Department of Respiratory Medicine (ward 14)
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130418

Study information

Scientific title

Acronym

Study hypothesis

It will help to determine the appropriate treatment parameter targets and in turn the most appropriate type of ventilator for patients undergoing non-invasive ventilation for chest wall and neuromuscular weakness. In addition it will help understanding the pathogenesis of respiratory failure in such patients

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Condition

Respiratory: Non-invasive ventilation

Intervention

Randomised controlled trial; Before-after trial Random allocation to [a] treatment a [b] treatment b

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Delivered tidal volume
2. minute ventilation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

16/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be asked to volunteer for the study from a patient base of approximately 70 patients whom are already established on non-invasive ventilation at home.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

70

Participant exclusion criteria

1. Change in ventilator or its settings within last 6 weeks
2. recent deterioration in condition
3. rapidly progressive disease
4. patient refusal

Recruitment start date

01/06/2002

Recruitment end date

16/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Respiratory Medicine (ward 14)
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

None

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17601720

Publication citations

  1. Results

    Tuggey JM, Delmastro M, Elliott MW, The effect of mouth leak and humidification during nasal non-invasive ventilation., Respir Med, 2007, 101, 9, 1874-1879, doi: 10.1016/j.rmed.2007.05.005.

Additional files

Editorial Notes