Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Obesity Hypoventilation Syndrome
Conditions
Brief summary
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.
Interventions
OTHERSurface parasternal electromyography (EMG) set up
Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Michelle Ramsay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients over the age of 16 years. 2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome. 3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of \>6.0 kPa in the morning. 4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of \>6.0 kPa during the day. 5. No prior domiciliary ventilation.
Exclusion criteria
1. Patients with other co-morbidities e.g. cancer or cardiac failure. 2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease. 3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. 4. Patients who have an abnormal bleeding tendency (INR or APTTr \>1.4 or platelets \<100). 5. Patients with a psychological, social or geographical situation that would impair compliance with the project.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence with ventilation | 3 months | Data on patient reported compliance and ventilator recorded compliance will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| health related quality of life | 3 month | SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire |
| length of hospital stay for initiation of home mechanical ventilation | 3 months | — |
| gas exchange | 3 months | overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide |
Countries
United Kingdom
Outcome results
None listed