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.|
|ClinicalTrials.gov Identifier: NCT01361451|
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : October 23, 2015
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|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|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|
- Readmission to hospital [ Time Frame: 28 days ]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 ]
- 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
- 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
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): NCT01361451
|St. Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Study Director:||Nicholas Hart, PhD||Guy's and St Thomas' NHS Foundation Trust|
|Principal Investigator:||Eui-Sik Suh, MBBS||King's College London|