Computer-assisted ALerting and Monitoring System

ISRCTN	ISRCTN72502609
DOI	https://doi.org/10.1186/ISRCTN72502609
Protocol serial number	N/A
Sponsor	Oxford BioSignals Ltd (UK)
Funder	Oxford BioSignals Ltd (UK)

Submission date: 13/05/2005
Registration date: 10/06/2005
Last edited: 30/07/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Duncan Young
Scientific

Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
United Kingdom

Phone	+44 (0)1865220621
Email	duncan.young@nda.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CALMS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key 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.
Key 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.
Date of first enrolment	01/10/2003
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Adult Intensive Care Unit

Oxford
OX39DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2006		Yes	No