Non Invasive ventilation (NIV) in chronic ventilatory failure: A comparison of different modes of ventilation and an analysis of mechanisms of action
| ISRCTN | ISRCTN33655313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33655313 |
| Secondary identifying numbers | RRCC820F 444354 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 03/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Justine Tuggey
Scientific
Scientific
24 West End Road
Calverley Pudsey
Leeds
LS28 5PF
United Kingdom
| Phone | +44 (0)1943 604785 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous system diseases: Other nervous system disease |
| Intervention | Pressure support ventilation vs volume cycled ventilation |
| Intervention type | Other |
| 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 study start date | 10/01/2000 |
| Completion date | 10/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added December 2008: 13 |
| Key inclusion criteria | Patients with established chronic respiratory failure due to chest wall deformity or neuromuscular weakness stable of home nocturnal non-invasive ventilation. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/01/2000 |
| Date of final enrolment | 10/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
24 West End Road
Leeds
LS28 5PF
United Kingdom
LS28 5PF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2005 | Yes | No |
