Guys and St Thomas NHS Foundation Trust
London, SE1 7EH, United Kingdom
NCT Number: NCT04848012
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
London, SE1 7EH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Exclusion criteria
Healthy participant inclusion criteria:
A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.
Time frame: 6 weeks
Number of hours spent on nocturnal ventilation therapy
Time frame: 1 night during single night admission
Mean nocturnal transcutaneous carbon dioxide level measured on single night admission
Time frame: 1 night during single night admission
Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission
Time frame: 1 night during single night admission
Sleep efficiency, measured by polysomnography
Time frame: 1 night during single night admission
Wake after sleep onset, measured by polysomnography
Time frame: 1 night during single night admission
Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography
Time frame: 1 night during single night admission
Apnoea/hypopnoea index, measured by polysomnography
Time frame: 1 night during single night admission
4 per cent oxygen desaturation index, measured by polysomnography
Time frame: 6 weeks
Inspiratory capacity following 6 weeks of each NIV device
Time frame: 6 weeks
Measured using COPD Assessment Test
Time frame: 6 weeks
Measured using Severe Respiratory Insufficiency Questionnaire
Time frame: 2 weeks
Measured using wrist actigraphs during the final 2 weeks of each 6 week arm
Guy's and St Thomas' NHS Foundation Trust
Other
Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease
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