Patient -Ventilator Interaction in Chronic Respiratory Failure

Phase 2

Completed

• Conditions: Chronic Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome; Neuromuscular Disease
• Interventions: Other: Surface parasternal electromyography (EMG) set up

• Registration Number: NCT01371149
• Lead Sponsor: Michelle Ramsay

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2014-01
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parasternal electromyography (EMG) set up	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.

Primary Outcome Measures

Name	Time	Method
Adherence with ventilation	3 months	Data on patient reported compliance and ventilator recorded compliance will be collected.

Secondary Outcome Measures

Name	Time	Method
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
health related quality of life	3 month	SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire

Trial Locations

Locations (2)

Guy's and St. Thomas' NHS Trust; 🇬🇧 London, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom