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This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe).
There is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms.
We hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life.
Patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. They will have baseline data recorded and then be followed up after each 6 week block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure support ventilation | Active Comparator | Pressure support ventilation |
|
| Pressure control ventilation | Active Comparator | Pressure control ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure support ventilation | Other | Pressure support ventilation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to ventilation | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood gases | 6 and 12 weeks | |
| Health related quality of life as measured by CRQ and SRI | 6 and 12 weeks | |
| Breathlessness (MRC dyspnoea score) |
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Inclusion Criteria:
Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of >70% and VC <50% predicted or patients with COPD with a FEV1/FVC ratio of <70% an FEV1 <50% predicted
Stable
Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
Arterial carbon dioxide partial pressure (PaCO2) > 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 >7.5KPa or a rise in TcCO2 of >1 KPa)
No prior domiciliary ventilation use
Patients with COPD must be established on optimal medical treatment prior to enrolment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Brignall, MB ChB | Contact | 0044 20 7188 7188 | 88070 | kate.brignall@gstt.nhs.uk |
| Patrick Murphy, MB BS | Contact | 0044 20 71887188 | 88070 | patrick.murphy@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| A Davidson, MA, MD | Guys's and St Thomas' NHS foundation trust | Study Chair |
| N Hart, MB BS, PhD | Guy's and St Thomas' Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23271905 | Derived | Murphy PB, Brignall K, Moxham J, Polkey MI, Davidson AC, Hart N. High pressure versus high intensity noninvasive ventilation in stable hypercapnic chronic obstructive pulmonary disease: a randomized crossover trial. Int J Chron Obstruct Pulmon Dis. 2012;7:811-8. doi: 10.2147/COPD.S36151. Epub 2012 Dec 11. |
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| Pressure control ventilation |
| Other |
Pressure control ventilation |
|
| 6 and 12 weeks |
| Assessment of daytime vigilance and fatigue by the Epworth sleepiness score,Oxford sleep resistance test and the fatigue severity score. | 6 and 12 weeks |
| Sleep comfort as assessed by a visual analogue scale | 6 and 12 weeks |
| Spirometry: forced expiratory volume in 1s and forced vital capacity | 6 and 12 weeks |
| Respiratory muscle strength: maximum inspiratory pressure, maximum expiratory pressure and sniff nasal pressure | 6 and 12 weeks |
| Sleep fragmentation as assessed by actigraphy | 2 week perids from 4 and 10 weeks |
| Patient ventilator synchrony as measured by number of ineffective efforts | 6 and 12 weeks |
| K Brignall, MB ChB |
| Guy's and St Thomas' NHS Foundation Trust |
| Principal Investigator |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
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