Myotrace: An Evaluation of a Novel Critical Illness Monitoring System

NCT01361451 | Completed

• 1 other identifier: RJ111/N002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

parasternal electromyogram; neural respiratory drive; chronic obstructive pulmonary disease; respiratory physiology; Acute exacerbation

Outcome Measures

Primary Outcomes (1)

• Readmission to hospital

  Readmission to hospital within 28 days of discharge, following acute exacerbation of COPD

  28 days

Secondary Outcomes (3)

• Length of hospital stay

  expected to be 2-9 days

• Physical activity

  Up to 3 months after discharge from hospital

• Treatment failure

  up to 1 month following admission

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised patients with acute exacerbation of chronic obstructive pulmonary disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• Patout M, Meira L, D'Cruz R, Lhuillier E, Kaltsakas G, Arbane G, Suh ES, Hart N, Murphy PB. Neural respiratory drive predicts long-term outcome following admission for exacerbation of COPD: a post hoc analysis. Thorax. 2019 Sep;74(9):910-913. doi: 10.1136/thoraxjnl-2018-212074. Epub 2019 Apr 26.

  PMID: 31028235 DERIVED

• Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.

  PMID: 26194996 DERIVED

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Hart, PhD

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

• Eui-Sik Suh, MBBS

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 26, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 23, 2015

Record last verified: 2010-11

Locations

GB (1)