Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement

What is it about?

Background and study aims: Despite best efforts, there is continuing evidence that a proportion of hospitalised patients worsen, sometimes due to reversible causes. Failure to identify and act on indicators of worsening acute illness in hospital wards is a problem that has been known for more than 10 years. “Track and Trigger” scoring systems are used in practice to check “standard" vital signs. These are pulse rate, respiratory rate, blood pressure, oxygen level and temperature. These are taken at timed intervals based on a protocol which is selected based on the clinical condition of the patient. Intermittent application of vital sign monitoring devices can be time-consuming. As a result the correct frequency of observations is often missed. Continuous vital sign monitoring within the ward environment is not currently workable, but it’s believed to increase the timely detection of patient deterioration. Wearable ambulatory monitoring systems (AMS) may provide an alternative continuous monitoring system which may improve the early detection of irregular physical and biological parameters. AMS would allow patients to be more mobile and have less discomfort. The aim of this study is to test whether the devices will be able to give correct readings and be suitable for clinical use. This is to ensure that AMS kits give accurate and reliable readings. To achieve this these kits need to be rigorously tested on up to 45 healthy volunteers. Who can participate? Men and women aged 18 or over and in generally good health; What does the study involve? Participants will be attached to a standard hospital monitor and the portable monitors being tested. A small tube will be inserted into their radial artery (called an arterial line). This will allow the study doctor to take blood samples during the study. Participants will be asked to follow a series of movements designed to mimic those commonly made by patients in hospital, such as drinking, standing and reading. They will then be asked to wear a tight-fitting mask attached to a machine. This will gradually lower the amount of oxygen in their blood. Throughout the study, blood samples will be taken from the arterial line to measure blood oxygen levels. At the end of the study the mask will be removed, oxygen levels returned to normal and the arterial line will be removed.

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