Patient -Ventilator Interaction in Chronic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-04-30

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physician led ventilator set up

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Surface parasternal electromyography (EMG) set up

Intervention Type OTHER

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

Interventions

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Surface 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No