Patient -Ventilator Interaction in Chronic Respiratory Failure

NCT01371149 | Completed Phase 2

• 1 other identifier: 10/H0716/67
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adherence with ventilation

  Data on patient reported compliance and ventilator recorded compliance will be collected.

  3 months

Secondary Outcomes (3)

• health related quality of life

  3 month

• length of hospital stay for initiation of home mechanical ventilation

  3 months

• gas exchange

  3 months

Study Arms (2)

Physician led ventilator set up

NO INTERVENTION

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

parasternal electromyography (EMG) set up

EXPERIMENTAL

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

Interventions

Surface parasternal electromyography (EMG) set up OTHER

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

parasternal electromyography (EMG) set up

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 16 years.
• Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
• Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of \>6.0 kPa in the morning.
• Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of \>6.0 kPa during the day.
• No prior domiciliary ventilation.

You may not qualify if:

• Patients with other co-morbidities e.g. cancer or cardiac failure.
• Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
• Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
• Patients who have an abnormal bleeding tendency (INR or APTTr \>1.4 or platelets \<100).
• Patients with a psychological, social or geographical situation that would impair compliance with the project.

Sponsors & Collaborators

• Michelle Ramsay: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (2)

Guy's and St. Thomas' NHS Trust

London, SE1 7EH, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Neuromuscular Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 10, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

GB (2)