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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16085730
Publication citations
-
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.