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Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.
Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.
The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.
Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.
Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual non-invasive ventilation | No Intervention | The usual therapy the participant is receiving via non-invasive ventilator. | |
| Auto-titrating non-invasive ventilation | Experimental | A novel auto-titrating non-invasive ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-titrating non-invasive ventilation | Device | A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to ventilation therapy | Number of hours spent on nocturnal ventilation therapy | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean nocturnal transcutaneous carbon dioxide level | Mean nocturnal transcutaneous carbon dioxide level measured on single night admission | 1 night during single night admission |
| Maximal nocturnal transcutaneous carbon dioxide level |
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Patient Inclusion Criteria:
Exclusion Criteria:
Healthy participant inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeraj Shah | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Nicholas Hart | Guy's and St Thomas' NHS Foundation Trust | Study Chair |
| Patrick Murphy | Guy's and St Thomas' NHS Foundation Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas NHS Foundation Trust | London | London | SE1 7EH | United Kingdom |
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12 weeks sequential (pre/post) study. Participants will receive usual NIV treatment for 6 weeks followed by novel ventilator for 6 weeks.
There will be a randomised crossover element for one night at the midpoint of the study to assess sleep parameters on the two ventilation modalities.
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Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission
| 1 night during single night admission |
| Sleep parameters | Sleep efficiency, measured by polysomnography | 1 night during single night admission |
| Sleep parameters | Wake after sleep onset, measured by polysomnography | 1 night during single night admission |
| Sleep parameters | Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography | 1 night during single night admission |
| Sleep parameters | Apnoea/hypopnoea index, measured by polysomnography | 1 night during single night admission |
| Sleep parameters | 4 per cent oxygen desaturation index, measured by polysomnography | 1 night during single night admission |
| Inspiratory capacity | Inspiratory capacity following 6 weeks of each NIV device | 6 weeks |
| Health-related quality of life | Measured using COPD Assessment Test | 6 weeks |
| Health-related quality of life | Measured using Severe Respiratory Insufficiency Questionnaire | 6 weeks |
| Daytime physical activity | Measured using wrist actigraphs during the final 2 weeks of each 6 week arm | 2 weeks |