ISRCTN ISRCTN72502609
DOI https://doi.org/10.1186/ISRCTN72502609
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study acronymCALMS
Study objectivesTo 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) studiedNon-invasive monitoring of patients undergoing high-risk surgery, or admitted for an acute medical problem.
InterventionComparison 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 typeProcedure/Surgery
Primary outcome measureThe 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 measures1. 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.
Overall study start date01/10/2003
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteriaMale 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 criteriaThose 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 enrolment01/10/2003
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Adult Intensive Care Unit
Oxford
OX39DU
United Kingdom

Sponsor information

Oxford BioSignals Ltd (UK)
Industry

Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom

Phone +44 (0)1865336170
Email enquiries@oxford-biosignals.com
ROR logo "ROR" https://ror.org/02q0ygf45

Funders

Funder type

Industry

Oxford BioSignals Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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