Patient -Ventilator Interaction in Chronic Respiratory Failure

Study Overview
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Brief Summary
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To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.

Official Title
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A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure

Conditions
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Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Neuromuscular Disease, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Surface parasternal electromyography (EMG) set up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 16 years. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day. No prior domiciliary ventilation. Exclusion Criteria: Patients with other co-morbidities e.g. cancer or cardiac failure. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100). Patients with a psychological, social or geographical situation that would impair compliance with the project.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physician led ventilator set up<br>Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach | |
| Experimental: parasternal electromyography (EMG) set up<br>Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony. | Other: Surface parasternal electromyography (EMG) set up<br>* Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence with ventilation | Data on patient reported compliance and ventilator recorded compliance will be collected. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life | SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire | 3 month | 
| length of hospital stay for initiation of home mechanical ventilation |  | 3 months | 
| gas exchange | overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide | 3 months |