Contact information
Type
Scientific
Primary contact
Dr John Duncan Young
ORCID ID
Contact details
Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
United Kingdom
+44 (0)1865220621
duncan.young@nda.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CALMS
Study hypothesis
To determine if advanced signal processing and data fusion techniques (contained in a novel computer module called the 'BioSign Monitor') when applied to physiological signals obtained from a standard patient monitor can detect clinically significant changes in the condition of patients differently to current standard care. Specifically patients will be monitored in the immediate post-operative period or following emergency admission to hospital for non-surgical conditions.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Non-invasive monitoring of patients undergoing high-risk surgery, or admitted for an acute medical problem.
Intervention
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 monitoring. Nested within the monitoring arm is a within-patient assessment of the senstivity and specificity of 'BioSign', a novel computer data fusion device which analyses physiological tracees in real time, to determine if it can detect the clinically significant events earlier than current monitoring and usual standards of care.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
1. To determine if the BioSign Monitor detects clinically significant deteriorations in the condition of patients before the patients 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.
Overall trial start date
01/10/2003
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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.
Recruitment start date
01/10/2003
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult Intensive Care Unit
Oxford
OX39DU
United Kingdom
Sponsor information
Organisation
Oxford BioSignals Ltd (UK)
Sponsor details
Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
+44 (0)1865336170
enquiries@oxford-biosignals.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Oxford BioSignals Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16707529
Publication citations
-
Results
Tarassenko L, Hann A, Young D, Integrated monitoring and analysis for early warning of patient deterioration., Br J Anaesth, 2006, 97, 1, 64-68, doi: 10.1093/bja/ael113.