Myotrace: An Evaluation of a Novel Critical Illness Monitoring System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01361451
First received: May 24, 2011
Last updated: May 25, 2011
Last verified: November 2010
  Purpose

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
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myotrace: A Phase II Evaluation of a Novel Critical Illness Monitoring System

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Readmission to hospital [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Readmission to hospital within 28 days of discharge, following acute exacerbation of COPD


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: expected to be 2-9 days ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Up to 3 months after discharge from hospital ] [ Designated as safety issue: No ]
    as measured by two types of activity monitor during hospital stay and up to 3 months after discharge

  • Treatment failure [ Time Frame: up to 1 month following admission ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalised patients with acute exacerbation of chronic obstructive pulmonary disease

Criteria

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
  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: NCT01361451

Contacts
Contact: Nicholas Hart, PhD 0207 188 7727 nicholas.hart@gstt.nhs.uk
Contact: Eui-Sik Suh, MBBS 0207 188 8070 eui-sik.suh@gstt.nhs.uk

Locations
United Kingdom
St. Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Eui-Sik Suh, MBBS    0208 188 8070    eui-sik.suh@gstt.nhs.uk   
Sub-Investigator: Eui-Sik Suh, MBBS         
Principal Investigator: Nicholas Hart, PhD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Study Director: Nicholas Hart, PhD Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Eui-Sik Suh, MBBS King's College London
  More Information

No publications provided

Responsible Party: Karen Ignatian, Guy's and St. Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01361451     History of Changes
Other Study ID Numbers: RJ111/N002
Study First Received: May 24, 2011
Last Updated: May 25, 2011
Health Authority: United Kingdom: Research Ethics Committee

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:
Critical Illness
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014