Condition category
Surgery
Date applied
13/05/2005
Date assigned
10/06/2005
Last edited
30/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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 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 trial start date

01/10/2003

Overall trial end date

30/06/2005

Reason abandoned

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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16707529

Publication citations

  1. 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.

Additional files

Editorial Notes