Patient -Ventilator Interaction in Chronic Respiratory Failure

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Michelle Ramsay, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01371149
First received: June 9, 2011
Last updated: April 2, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Adherence with ventilation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Data on patient reported compliance and ventilator recorded compliance will be collected.


Secondary Outcome Measures:
  • health related quality of life [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • gas exchange [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 9, 2011
Last Updated: April 2, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014