The Computer-assisted ALerting and Monitoring System study is a randomised controlled trial of continuous physiological monitoring. It is a combined venture between the University of Oxford and Oxford BioSignals Ltd (a spin out company from the University).

The venture has been initiated to attempt to provide a method of improving the equipment available to all ward staff to identify earlier patient deteriorations. As it has been documented that catastrophic deterioration of patients in hospital is frequently preceded by a change in physiological variables that may pass unnoticed or unrecognized for a considerable period of time. This may lead to potentially avoidable unexpected deaths, increased length of hospital stay or to a poorer eventual functional outcome following ICU admission. Early recognition and correction of physiological abnormalities may result in an improvement in functional outcome or mortality. Even if patients are connected to multi-channel continuous physiological monitoring important changes heralding a catastrophic decline may go undetected, either because the pattern of decline is not recognized by the ward staff or because existing monitors only alarm when a single variable falls outside a wide range defining "normality".

This joint venture has developed and previously piloted a novel computer module called the "Software Monitor". The Software Monitor can be plugged into the back of any standard PROPAQ machine and has been trained to detect clinically significant changes in the condition of patients differently to current standard care, by utilizing the values of all 5 parameters (BP, temperature, HR, SpO2, and RR) not just one.

The primary goal of the project is to determine the specificity and sensitivity of the Software Monitor to detect clinically significant deteriorations in the condition of patients in the 72 hours following major surgery, following emergency admission or if a patients condition has suddenly deteriorated. The "gold standard" against which the Software Monitor will be compared is the rate of clinically significant events detected using standard care alone by the ward care team.

This randomized controlled trial (RCT) of n=306 patients will determine if:

• "Mandated continuous physiological monitoring alters the rate of clinically significant events detected?" and,
• "If the Software Monitor detects these events with suitable sensitivity and specificity?"

Participating trial centres currently are:

• The acute hospitals of the Oxford Radcliffe Trust

Trial Coordinator
Dr V S Barber
Kadoorie Centre for Critical Care Research and Education
Level 3b
The John Radcliffe Hospital
Headley Way
Headington OXFORD OX3 9DU

Inclusion Criteria

• Aged > 18 years
• Must be deemed by the attending physician/surgeon to have a risk greater than 5% of serious morbidity from either surgery or an acute medical condition
• Must have given signed, informed consent

Patient Exclusions

• Patients undergoing cardiac surgery
• Patients undergoing surgery for burns
• Patients undergoing surgery of the thoracic aorta
• Patients that are pregnant
• Patients who have been sectioned
• Patients with a learning disability
• Patients whose anatomy precludes the use of the required monitoring

Follow up

• Following randomisation patients will be either attached to the Software Monitor and receive 5 channel continuous physiological monitoring or will receive usual standard of care monitoring.
• Patient notes will be scrutinized every 24 hours and any significant clinical events extracted onto data collections forms.
• After 96 hours patients will complete their participation in the study and will not be followed up.