Patient -Ventilator Interaction in Chronic Respiratory Failure

Michelle Ramsay

Status and phase: Completed; Phase 2

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

Treatments: Other: Surface parasternal electromyography (EMG) set up

Study type: Interventional

Funder types: Other

Identifiers

NCT01371149

10/H0716/67

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Physician led ventilator set up

No Intervention group

Description:

Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach

parasternal electromyography (EMG) set up

Experimental group

Description:

Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Treatment:

Other: Surface parasternal electromyography (EMG) set up