Efficacy of an Advanced Auto-titrating NIV in COPD
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual non-invasive ventilation The usual therapy the participant is receiving via non-invasive ventilator. |
|
| Experimental: Auto-titrating non-invasive ventilation A novel auto-titrating non-invasive ventilator |
Device: Auto-titrating non-invasive ventilation
A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.
|
Outcome Measures
Primary Outcome Measures
- Adherence to ventilation therapy [6 weeks]
Number of hours spent on nocturnal ventilation therapy
Secondary Outcome Measures
- Mean nocturnal transcutaneous carbon dioxide level [1 night during single night admission]
Mean nocturnal transcutaneous carbon dioxide level measured on single night admission
- Maximal nocturnal transcutaneous carbon dioxide level [1 night during single night admission]
Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission
- Sleep parameters [1 night during single night admission]
Sleep efficiency, measured by polysomnography
- Sleep parameters [1 night during single night admission]
Wake after sleep onset, measured by polysomnography
- Sleep parameters [1 night during single night admission]
Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography
- Sleep parameters [1 night during single night admission]
Apnoea/hypopnoea index, measured by polysomnography
- Sleep parameters [1 night during single night admission]
4 per cent oxygen desaturation index, measured by polysomnography
- Inspiratory capacity [6 weeks]
Inspiratory capacity following 6 weeks of each NIV device
- Health-related quality of life [6 weeks]
Measured using COPD Assessment Test
- Health-related quality of life [6 weeks]
Measured using Severe Respiratory Insufficiency Questionnaire
- Daytime physical activity [2 weeks]
Measured using wrist actigraphs during the final 2 weeks of each 6 week arm
Eligibility Criteria
Criteria
Patient Inclusion Criteria:
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Age ≥ 18 years
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BMI <30 kg/m¬2
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Confirmed diagnosis of COPD
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Currently using domiciliary NIV with average reported compliance of at least 3hours
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Ability to provide informed consent
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Medical stability confirmed by recruiting physician
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Free of exacerbations for at least 2 weeks prior to enrolment
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Presence of expiratory flow limitation on forced oscillation technique criteria
Exclusion Criteria:
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Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
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Presence of major medical comorbidity, e.g. severe heart failure (LVEF <30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
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Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
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Psychosocial factors that would prevent compliance with study protocol
Healthy participant inclusion criteria:
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Age ≥ 18 years
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No expiratory flow limitation on forced oscillation testing
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No acute illness on study day
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Ability to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guys and St Thomas NHS Foundation Trust | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
Investigators
- Principal Investigator: Neeraj Shah, Guy's and St Thomas' NHS Foundation Trust
- Study Chair: Nicholas Hart, Guy's and St Thomas' NHS Foundation Trust
- Study Director: Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 279564