Non-invasive monitoring of patients undergoing high-risk surgery, or admitted for an acute medical problem. Surgery
Conditions
Interventions
Comparison of effect of mandated 4/5 channel physiological monitoring on clinically significant event rates in high-risk patients compared to patients in the same group receiving usual care and monito
Sponsors
Oxford BioSignals Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients, 18 years or older, undergoing 'high-risk' elective or emergency surgical procedures, or presenting with an acute medical problem of at least moderate severity.
Exclusion criteria
Exclusion criteria: Those subject to additional protections; this includes pregnant women and persons with mental illness or disability, patients refusing consent, children (less than 18 years old), patients undergoing cardiac surgery, patients undergoing surgery for burns, patients undergoing surgery of the thoracic aorta, patients whose anatomy precludes the use of the required monitoring, patients expected to be sufficiently mobile to leave the bed space unaided within 72 hours of operation or recruitement. Patients in the intensive care unit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of the study is to determine the specificity and sensitivity of a package of signal processing and data fusion techniques (the 'BioSign Monitor') to detect clinically significant deteriorations in the condition of patients in the 72 hours following major surgery or emergency admission. The 'gold standard' against which the BioSign Monitor will be compared is the rate of clinically significant events detected using standard care alone by the ward care team. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine if the BioSign Monitor detects clinically significant deteriorations in the condition of patients before the patient?s care team notes them 2. To determine if the BioSign Monitor, using pattern recognition techniques integrated over five physiological variables, can predict clinically significant changes in a single physiological variable before they are detected by single channel limit alarms 3. To determine if mandated continuous standard 5 channel physiological monitoring alters the rate of detection of clinically significant events 4. To determine if mandated continuous 5 channel physiological monitoring alters the hospital mortality or hospital length of stay in patients following major surgery or following emergency admission 5. To determine the optimal threshold for event detection in the BioSign Monitor to maximize true positive detections and minimize false positive and false negative detections 6. To provide a high quality, well annotated database of physiological data on post-operative and urgent medical patients to allow further development of data fusion algorithms. | — |
Countries
United Kingdom
Outcome results
None listed