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Patient -Ventilator Interaction in Chronic Respiratory Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371149
First Posted: June 10, 2011
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust
  Purpose
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 Intervention Phase
Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Neuromuscular Disease Chronic Obstructive Pulmonary Disease Other: Surface parasternal electromyography (EMG) set up Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust:

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


Secondary Outcome Measures:
  • health related quality of life [ Time Frame: 3 month ]
    SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire

  • length of hospital stay for initiation of home mechanical ventilation [ Time Frame: 3 months ]
  • gas exchange [ Time Frame: 3 months ]
    overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide


Enrollment: 58
Study Start Date: January 2011
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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
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

Responsible Party: Michelle Ramsay, Dr, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01371149     History of Changes
Other Study ID Numbers: 10/H0716/67
First Submitted: June 9, 2011
First Posted: June 10, 2011
Last Update Posted: April 3, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Neuromuscular Diseases
Hypoventilation
Hypercapnia
Obesity Hypoventilation Syndrome
Respiratory Tract Diseases
Respiration Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders