Myotrace: An Evaluation of a Novel Critical Illness Monitoring System
Recruitment status was Recruiting
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Myotrace: A Phase II Evaluation of a Novel Critical Illness Monitoring System|
- 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
- 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
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361451
|Contact: Nicholas Hart, PhD||0207 188 firstname.lastname@example.org|
|Contact: Eui-Sik Suh, MBBS||0207 188 email@example.com|
|St. Thomas' Hospital||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Eui-Sik Suh, MBBS 0208 188 8070 firstname.lastname@example.org|
|Sub-Investigator: Eui-Sik Suh, MBBS|
|Principal Investigator: Nicholas Hart, PhD|
|Study Director:||Nicholas Hart, PhD||Guy's and St Thomas' NHS Foundation Trust|
|Principal Investigator:||Eui-Sik Suh, MBBS||King's College London|