Computer-assisted ALerting and Monitoring System
| 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
Scientific
Adult Intensive Care Unit
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
United Kingdom
| Phone | +44 (0)1865220621 |
|---|---|
| duncan.young@nda.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 | 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 study start date | 01/10/2003 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Adult Intensive Care Unit
Oxford
OX39DU
United Kingdom
OX39DU
United Kingdom
Sponsor information
Oxford BioSignals Ltd (UK)
Industry
Industry
Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
| Phone | +44 (0)1865336170 |
|---|---|
| enquiries@oxford-biosignals.com | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
