Hypothermia Following Anesthesia Clinical Trial
Official title:
An Observational Thermography Study of the Core-peripheral Temperature Gradient as a Function of Vascular Resistance During the Redistribution Phase Following the Induction of General Anaesthesia in Warmed and Non-warmed Patients
The purpose of the study is to assess the temperature changes that take place throughout the body in a real world setting, when a patient is given general anaesthesia. Specifically we will investigate the movement of body heat from the core to the peripheries at the beginning of surgery. This will be measures with a series of temperature sensors and infrared thermography
Intra-operative hypothermia increases the risk of a wide range of post operative
complications; wound infection, damage to heart muscle, and an increased length of hospital
stay.
A range of technologies exist for maintaining the temperature of patients undergoing
surgical procedures. Yet despite the frequent use of forced air warming devices, a
significant reduction in core temperature can occur in the first 60 minutes of some major
surgeries.
This is an Observational Cross-Sectional Study, investigating patients undergoing elective
surgery in two groups Group 1: Patients undergoing brief surgical procedures of >15 minutes
for whom no warming devices are being employed.
Group 2: Patients undergoing surgical procedures in which forced air warming, is being used
Potential participants will first be approached by medical staff at their pre-operative
assessment clinic. They will be screened for exclusion criteria before being given a
participant information sheet, which will be explained to them. They will be invited to
contact the researcher if they are interested in participating in the study.
On arrival in hospital the day of their surgery, the patients will be met by their
anaesthetist and a researcher who will provide any further information required about the
study, and consent will be taken.
Following receipt of informed consent, patients will be involved from 30 minutes before
their surgery begins, until the end of their surgery.
The null hypothesis is that there is no difference in the rate of flow of heat from the core
to the peripheries between patients who receive warming during surgery, and those who do
not. As it would be unethical to randomise a patient to not receive warming, we have
designed an observational study to compare patients who are warmed / not warmed as part of
their standard care. Patients undergoing surgery <30 minutes long are not routinely warmed
during surgery.
Potential participants will be informed of the study at the pre-operative assessment clinic
in the weeks preceding surgery. Posters will be located in the clinic rooms and relevant
areas, and subjects will be given information by the clinic staff to read prior to their
surgery.
Participants will be admitted to hospital the evening prior, or the morning of surgery,
whereupon they will undergo standard admission processes, including pre-operative assessment
by the anaesthetist assigned to that list. The anaesthetist and researcher will then explain
the study again, reiterating the potential risks and benefits of the study to the patient
themselves, and to the population as a whole. Written consent will be sought at this point.
Participants will be weighed and four measurements will be taken, comprising : arm length,
leg length, trunk length and maximum abdominal width. Participants will stand onto a
bioimpedance machine, which will quantify their body fat and body water percentage.
30 minutes before their operation, skin temperature sensors will be placed on the patient's
forehead, forearm, finger, hip, calf and toe. An additional SpotOn temperature sensor,
placed on the forehead will be used to non invasively measure core temperature.
Measurement of blood pressure, cardiac output and systemic vascular resistance will be
obtained by a finger cuff connected to a Nexin Noninvasive cardiac output monitor. These
measurements describe the action of the heart and blood vessels. At the end of each surgery
the data recorded on this device will be transferred via an encrypted USB key onto a data
acquisition laptop.
Temperature measurements from the seven of sensors will taken at 5 second intervals onto a
data acquisition laptop.
At 15 minutes intervals Infra red thermography images will be taken from a FLIR a320 device.
This equipment will be mounted on a raised boom above the surgeons, in a sterile sleeve.
This will not be held over the patient at any point, and will be moved away from the patient
between measurements.
Once the surgery has ended, and the patient has been transferred to the recovery area, all
temperature sensors will be removed and the patient will exit the trial.
A sample size of 24 patients will be recruited to quantify the effect of warming.
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