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Myotrace: An Evaluation of a Novel Critical Illness Monitoring System

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. Identifier: NCT01361451
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : October 23, 2015
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

There are 24,000 admissions each year to Intensive Care Units (ICU) in the United Kingdom due to pneumonia, asthma and a common condition called chronic obstructive pulmonary disease (COPD), with rates of death of 10%, 40% and 50%, respectively. These conditions account for 10% of all ICU admissions. It is therefore important to find out if it would be possible to detect deteriorations in patients with breathing problems early, in order to increase appropriately their level of care.

Clinical early warning scores (EWS) are used in many hospitals to detect patients whose medical condition is getting worse, and who are likely to need admission to intensive care or high dependency care units. EWS are usually calculated from several measurements taken from the patient, such as blood pressure, temperature and heart rate. However, they are often inaccurate as they need to be calculated manually by nursing staff from a number of measurements taken from a variety of different devices. Furthermore, even when accurately calculated, it is not clear how helpful EWS are in predicting whether or not patients will deteriorate.

Neural respiratory drive (NRD) is an objective indicator of breathlessness, and can be derived from the amount of electrical activity occurring in certain muscles used in breathing. The Myotrace system measures this electrical activity, as well as measurements such as rate of breathing and heart rate. It then analyses these measurements together to help identify patients at risk of deterioration.

This study will use Myotrace to monitor patients with severe breathing difficulties due to an acute worsening of chronic obstructive pulmonary disease, for early identification of failure to respond to medical treatment.

Patients will be recruited at St. Thomas' Hospital.

This research is funded by the Guy's and St. Thomas' Charity.

Condition or disease
Chronic Obstructive Pulmonary Disease

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myotrace: A Phase II Evaluation of a Novel Critical Illness Monitoring System
Study Start Date : January 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Primary Outcome Measures :
  1. Readmission to hospital [ Time Frame: 28 days ]
    Readmission to hospital within 28 days of discharge, following acute exacerbation of COPD

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: expected to be 2-9 days ]
  2. Physical activity [ Time Frame: Up to 3 months after discharge from hospital ]
    as measured by two types of activity monitor during hospital stay and up to 3 months after discharge

  3. Treatment failure [ Time Frame: up to 1 month following admission ]
    • Transfer to High Dependency Unit
    • Arterial blood gas demonstrating respiratory failure requiring non-invasive ventilation, if appropriate
    • Transfer to ICU
    • Arterial blood gas demonstrating respiratory failure requiring invasive ventilation, if appropriate
    • Hospital Mortality

Biospecimen Retention:   Samples With DNA
It is envisaged that a subset of patients will have venous blood samples taken for future analysis for inflammatory cytokines

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalised patients with acute exacerbation of chronic obstructive pulmonary disease

Inclusion Criteria:

  • Admitted patients with physician diagnosis of AECOPD
  • Smoking history ≥ 10 pack years, consistent with COPD
  • Expected to remain an inpatient for ≥ 24 hours
  • Age ≥ 35 years
  • Able to give informed consent to participation in the study

Exclusion Criteria:

  • Requirement for immediate mechanical ventilation at admission
  • Presence of another acute pathology (such as pulmonary embolism, pneumonia or pulmonary oedema) to explain the acute presentation
  • Presence of other severe medical problem, e.g. cancer
  • Psychological and social factors that would impair compliance with the study schedule

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 identifier (NCT number): NCT01361451

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United Kingdom
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
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Study Director: Nicholas Hart, PhD Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Eui-Sik Suh, MBBS King's College London
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust Identifier: NCT01361451    
Other Study ID Numbers: RJ111/N002
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: November 2010
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
parasternal electromyogram
neural respiratory drive
chronic obstructive pulmonary disease
respiratory physiology
Acute exacerbation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Critical Illness
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes