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Completed

NCT Number: NCT01371149

Patient -Ventilator Interaction in 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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Adherence with ventilation

    Time frame: 3 months

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

Secondary outcomes

  1. health related quality of life

    Time frame: 3 month

    SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire

  2. length of hospital stay for initiation of home mechanical ventilation

    Time frame: 3 months

  3. gas exchange

    Time frame: 3 months

    overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide

Sponsors and collaborators

Lead sponsor

Michelle Ramsay

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2011
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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