Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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 Justine Tuggey

ORCID ID

Contact details

24 West End Road
Calverley Pudsey
Leeds
LS28 5PF
United Kingdom
+44 (0)1943 604785

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC820F 444354

Study information

Scientific title

Acronym

Study hypothesis

NIV is an effective treatment for patients with ventilatory failure due to chest wall deformity, neuromuscular disease and some patients with lung disease. NIV during sleep improves oxygenation and transcutaneous CO2 overnight, together with an improvement in sleep quality and daytime arterial blood gas tensions. It has been postulated that either control of nocturnal hypoventilation with resetting of central drive, or the relief of chronic respiratory muscle fatigue is the crucial factor determining success. Some studies have shown that the improvement in daytime arterial blood gas tensions relates to a resetting of the central respiratory controller, but not to changes in respiratory muscle function. However Schoenhofer showed that NIV used for 8 hours per day during wakefulness was just as effective at improving arterial blood gas tensions as 8 hours per day during sleep. There was a significant improvement in respiratory muscle strength, without any change in central respiratory drive, and they postulated that NIV "works" by improving respiratory muscle function.
This distinction is important since the mechanism by which NIV "works" should determine the treatment endpoint, i.e. abolition of respiratory muscle activity to achieve complete muscle rest or improved sleep efficiency and optimisation of blood gas tensions overnight to restore central respiratory drive and improve sleep quality, with consequent beneficial effects upon daytime function. In turn this may affect the choice of ventilator that is to be used; for instance pressure support ventilation (PSV), in which the ventilator is triggered into inspiration and expiration according to patient effort, results in less complete muscle rest but may be more comfortable than full pressure controlled ventilation (PCV), during which the patient is required to make no respiratory effort. However, the cost of achieving complete muscle rest may be higher inflation pressures and an imposed pattern of breathing, which patients may find uncomfortable, and that compromises sleep quality.
We plan a comparison of pressure support ventilation against volume cycled ventilation in a one month randomised crossover trial to identify the relative importance of respiratory muscle fatigue and central respiratory drive in chronic respiratory failure. This will help to identify treatment endpoints in establishing patients on home non-invasive ventilation.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous system diseases: Other nervous system disease

Intervention

Pressure support ventilation vs volume cycled ventilation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Arterial blood gas tensions (pO2, PCO2)

Secondary outcome measures

1. Exercise tolerance (shuttle walk tests)
2. Psychometric tests
3. Central respiratory drive (using ventilatory and PO.1 response to carbon dioxide)
4. Assessment of respiratory muscle strength (sniff nasal pressures).
5. Full polysomnography (sleep quality and efficiency)
6. Health status

Overall trial start date

10/01/2000

Overall trial end date

10/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with established chronic respiratory failure due to chest wall deformity or neuromuscular weakness stable of home nocturnal non-invasive ventilation.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added December 2008: 13

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/2000

Recruitment end date

10/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

24 West End Road
Leeds
LS28 5PF
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16085730

Publication citations

  1. Results

    Tuggey JM, Elliott MW, Randomised crossover study of pressure and volume non-invasive ventilation in chest wall deformity., Thorax, 2005, 60, 10, 859-864, doi: 10.1136/thx.2005.041327.

Additional files

Editorial Notes