Patient -Ventilator Interaction in Chronic Respiratory Failure

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's and St. Thomas' NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Physician led ventilator set up; Patients will be set up on non-invasive ventilation as per the current gold standard physician led approach
Experimental: 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.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michelle Ramsay
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 3, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: 10/H0716/67