A Study To Determine The Accuracy Of Zero-Flux And Ingestible Thermometers In The Perioperative Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes.
研究概览
简要总结
Background When a patient is anesthetised and undergoes an operation, their body temperature falls. Managing a body temperature properly by keeping it within normal limits has been shown to improve recovery from surgery.
A vital part of managing temperature is being able to measure it properly. There are several ways of doing so, which consist of invasive methods such as temperature probes in the oesophagus and bladder, and non invasive methods such as infrared scanners and ear canal probes. During an operation, temperature changes as small as 0.5 °C can affect outcomes but, currently, only invasive methods are reliable enough to detect this. Oesophageal probes can't be used in patients who are not anaesthetised during their operations, and it is inappropriate to insert a urinary catheter should it not be otherwise needed.
The purpose of this study is to look at two new methods of measuring a patient's temperature which would help us in these situations. The first is called zero-flux thermometry and involves placing an adhesive pad to the forehead, which gives constant measurement of a patient's core temperature. The second involves swallowing an ingestible capsule that is no bigger than a normal pill. This technique has been very useful in research tracking a patient's core temperature as they are transferred through different areas over a longer period of time. Whilst these two methods are potentially very useful, they have never been tested on hospital patients.
Aims:
The investigators want to determine whether readings from these thermometers are accurate enough to be used in patients before, during and after surgery. Should they prove to be sufficiently accurate it will allow us to improve patient care through both clinical practice and research.
Plan:
During operations, temperature is routinely measured in line with NICE guidelines with a thermometer placed in the nose or oesophagous. The investigators will not be changing routine practice in any way, but checking measurements from the new devices against the proven, routine ones.
The investigators plan to record measurements from each device every minute throughout the operation in 20 patients. The investigators will then perform statistical tests to check their accuracy.
Study Hypothesis: Zero flux and ingestible thermometers are not significantly different at detecting patients body temperature than oesophageal temperature probes
详细描述
Summary:
The study has been designed to provide information on the suitability and accuracy of two methods of temperature measurement in the perioperative period.
Background:
Good perioperative temperature management is an important means of improving patient outcome [1].
An essential part of optimal management is accurate temperature measurement. The gold standard is pulmonary artery catheter (PAC) measurement. However, these are used infrequently in British practice due to the high rates of associated complications. Urinary bladder and oesophageal temperatures are sufficiently accurate but are unsuitable for many patients [2]. For example it is not possible to use oesophageal probes in awake patients and many patients are not catheterised.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre.
排除标准
- •Lacking mental capacity
- •Not speaking English
- •Malignancy in medical history
- •Undergoing open abdominal surgery
结局指标
主要结局
Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Dr C. Mark Harper
Dr C. Mark Harper Consultant Anaesthetist
Brighton and Sussex University Hospitals NHS Trust