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Patient -Ventilator Interaction in Chronic Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01371149
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Neuromuscular Disease Chronic Obstructive Pulmonary Disease Other: Surface parasternal electromyography (EMG) set up Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure
Study Start Date : January 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence with ventilation [ Time Frame: 3 months ]
    Data on patient reported compliance and ventilator recorded compliance will be collected.


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371149


Locations
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United Kingdom
Guy's and St. Thomas' NHS Trust
London, United Kingdom, SE1 7EH
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Michelle Ramsay
Royal Brompton & Harefield NHS Foundation Trust
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Michelle Ramsay, Dr, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01371149    
Other Study ID Numbers: 10/H0716/67
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Hypoventilation
Obesity Hypoventilation Syndrome
Neuromuscular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Nervous System Diseases
 Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders