This study aimed to determine if the Traxit temperature monitor (newly available at our institution, cheap, easy to use in many clinical settings, non-invasive and quick to apply) produced readings that agreed with the conventional standard of care sufficiently well to allow substitution in our clinical setting.
This study found that the Traxit thermometer did not perform adequately enough to be used during general anaesthesia. None of the sites tested achieved the clinically relevant predetermined limits of agreement (+/− 0.5 °C).
Our understanding of thermoregulation and anaesthesia has progressed significantly over the last 30 years. Hypothermia is defined as a body temperature reading below 36.0 °C [2]. It is associated with many negative clinical consequences including altered pharmacodynamics and pharmacokinetics, poor wound healing, and patient discomfort with shivering on waking or during awake procedures [2]. Shivering also causes increased oxygen demand and impairs monitoring devices causing artefacts on ECG and NIBP readings. Monitoring for hyperthermia, especially in patients being actively warmed, is as important as monitoring for hypothermia. It assists in detecting pathologies (e.g. malignant hyperthermia) and prevents the increased metabolic demand of hyperpyrexia. Many regions in the world demand the maintenance of normothermia as part of their national guidelines and minimum standards, and some regions, notably in the USA, may withhold full payment if normothermia is not maintained during anaesthesia [9, 10]. The maintenance of normothermia has become a crucial component of providing anaesthesia and an essential part of a patient’s journey through anaesthesia [9].
Body temperature is not homogeneous [2]: the temperature of deep thoracic, abdominal, and central nervous system (considered core temperature) usually range in temperature, the arms and legs are cooler and much of the skin surface is cooler still although also heterogeneously distributed. Unlike core temperature, which is tightly regulated, skin temperature can vary considerably. It is a function of environmental exposure and depends on exposure, central compartment temperature and thermoregulatory vasomotor activity [1]. Due to multiple factors there is no single tissue temperature that can be considered a “gold standard”. Core temperature can be determined by measuring temperature in the nasopharynx, with a pulmonary artery catheter or in the distal oesophagus. Carefully obtained oral, axillary and bladder temperatures have been shown to approximate core temperatures sufficiently for clinical use. Axillary, oral or forehead skin surface temperatures have previously been substituted for oesophageal or nasopharyngeal temperatures during regional anaesthesia [11].
Earlier reviews of non-invasive temperature monitors have shown varied results and provided confusing conclusions. As shown by Hooper and Andrews [11] the results they reported indicated that tympanic monitoring is commonly used but high-quality evidence supporting the accuracy of tympanic thermometry is lacking, and in fact, the most recent high-quality studies evaluating the accuracy of this instrument fail to show support for its use. This is further seen in practice when the measurement of core body temperature, depending on what method is used and where the measurement is made, is subject to considerable error [12]. It is noted in the 2018 update of the NICE guidance on Hypothermia [13] that healthcare professionals should be aware of, and carry out, any adjustments that need to be made in order to obtain an estimate of core temperature from that recorded at the site of measurement and be aware of any such adjustments that are made automatically by the device used. It highlights the inaccuracies of axilla and sublingual readings. It goes on to warn health care professionals of possible inaccuracies in core temperature estimation when using peripheral sites, such as sublingual or axilla, especially in patients whose core temperature is outside the normothermic range. An indirect estimate of core temperature is the reading produced by a thermometer after a correction factor has been applied, this adds a layer of inaccuracy.
Accurately measuring a patient’s temperature remains an inherently essential step in maintaining normothermia. An appropriately placed oesophageal temperature probe has been shown to approximate core body temperature. However, the placement of an oesophageal temperature probe is a semi-invasive technique and not well tolerated by awake patients. To date there are many suitable methods to measure a patient’s temperature when they are awake, however they are not available at our institution. Semi or non-invasive temperature monitors include the SpotOn Thermometer [5] (single-use sensor consists of a thermal insulator adjacent to the skin which is covered by a flex circuit, the flex circuit actively regulates its temperature to create a zone of perfect insulation), DoubleSensor thermometer [6] (which consists of two temperature probes on each side of a standardized insulator, one side adjacent to the patient’s skin and the other facing the environment, the heat coefficient of the insulating material is known and core temperature can be calculated using a proprietary formula) and the Temple Touch Pro [7] (which estimates core temperature from skin over the temporal artery but also requires separate monitor and display unit).
An alternative temperature monitoring device available at our institution is the Traxit® Wearable Children’s Underarm Thermometer. This thermometer utilises liquid crystals that have phase change properties when heated and is read using a dot matrix grid. The purported advantage of such a monitor is that it could be placed on the patient before anaesthesia while in the ward and could serve as the sole temperature monitor throughout the patient’s anaesthetic journey from ward to theatre and back again. Unfortunately, they were shown not to be of clinical value.
This study used Altman-bland plots to compare two methods of measurement, the pharyngeal/oesophageal thermistor (the standard of care at our institution) and the Traxit® Wearable Children’s Underarm Thermometer. Altman-bland plots are considered superior to simple regression/correlation analysis. Previous studies comparing non-invasive temperature monitors used similar methods to analysis performance of monitors. Kimberger et al. [6] collected data from 56 patients (general anaesthesia and regional anaesthesia) and found the average bias to be − 0.13 °C with narrow limits of agreement (− 0.65 to 0.40 °C). The Spoton deep forehead non-invasive temperature monitor was evaluated by Kato [5] in 2015. Kato examined 20 patients following cardiac surgery and compared the Spoton thermometer to the pulmonary artery catheter thermometer, they were able to collect and analyse over 16,000 data points. Altman-Bland plots were again used and clinical limits of agreement were agreed to be +/− 0.5 °C. A bias of − 0.28 °C with narrow limits of agreement were found. In 2017 Evron and colleges [7] examined the Temple Touch Pro device, they also used Altman-bland plots to compare the Temple Touch Pro to reference temperature measured in the naso-pharynx or oesophagus. Evron tested the hypothesis that the Temple touch pro non-invasive temperature measurement system estimates core temperature to within 0.5 °C of reference values. They were able to conclude cutaneous temporal TTP temperatures were sufficiently accurate for routine clinical use, with 94% of all measurements across a range of ages and types of surgery being within ±0.5 °C of reference distal oesophageal or naso-pharyngeal reference core temperatures. This study clearly shows that the Traxit® Wearable Children’s Underarm Thermometer is not of clinical value. Traxit® Wearable Children’s Underarm Thermometer had bias values of − 0.43 °C (behind the ear (over major vessels to the brain)), − 0.26 °C (in the axilla), − 0.66 °C (sternum) and − 0.66 °C (forehead) with wide limits of agreement. None of the results fell within the pre-defined clinical limits of agreement of +/− 0.5 °C.
Importantly, 55 of the 400 (14%) monitors failed to give a reading above 35 °C, the minimum displayed temperature of the Traxit® Wearable Children’s Underarm Thermometer. This was a notable finding when compared to the reliability of the oesophageal temperature monitor which never failed to heat up.
Forced air warming devices (FAW) were placed at the discretion of the individual anaesthetic providers based on their assessment of patient and surgical factors. FAW devices consist of a heat generating device and a fan or blowing system connected to a perforated ‘blanket’ that is placed over the patient. Many devices are available, the Bair Hugger 3 M is available in the intuition that conducted this study. It has three temperature settings and two fan modes. They work by radiant shielding and convection. They provide a buffer of warm air over the patient’s skin so heat loss via radiation is minimised. FAW devices heat the patient’s skin by convection/facilitated conduction by inducing a flow of warm air over the patient’s skin. Ambient temperature should not affect the monitor as they are insulated but the mechanism of FAW devices may impact on the accuracy of the surface skin temperature monitors. This was investigated by separating out the study participants into those where a FAW device was used and those where one was not used. The use of a FAW did not impact the results, in that no monitors provided reading within the pre-determined limits of agreement. The use of a FAW impacted readings by falsely increasing the temperature readings.
A theoretical limitation of skin temperature monitoring is the establishment of a peripheral to core temperature gradient. This gradient develops as the patient vasoconstricts in the presence of hypothermia to preserve heat and maintain core temperature. Skin temperature is often quoted as being up to 2 °C cooler than core temperature. However, the thermoregulatory response to hypothermia is reduced when under general anaesthesia. The threshold for skin vasoconstriction is reduced, and only becomes active at core temperatures less than 34.5 °C [9, 10]. This, in combination with the vasodilatory effects of general anaesthetic agents (propofol, volatile agents and regional techniques), makes interpreting and assigning a definitive number to skin temperatures in relation to core temperatures under anaesthesia difficult. It is also noted that temperature of vital organs is not homogenous, for example the brain may be warmer than the kidneys. Also, skin temperature has a wide variation determined by exposure and proximity to the central components. Big toe temperatures are different to axillary temperatures which in turn are different to forehead temperatures. This study aimed to find a suitable device that could substitute the standard of care in our facility which is the pharyngeal/oesophageal thermistor.
FAW devices may be better at preventing hypothermia than correcting it once hypothermia and vasoconstriction is established. Heating of the skin may not translate into core temperature warming until skin perfusion has improved, vasoconstriction has reversed and the causes of heat loss abated. However, local warming of the skin may improve local circulation even in the presence of central hypothermia [14]. The effect of a FAW are difficult to predict and may serve to only externally warm the monitoring device and not represent a true skin temperature reading.
Further limitations to this study are, the pragmatic sampling used may limit the reproducibility of the study as it resulted in a heterogenous patient and surgical population being studied. Thermodynamics of an obese patient presenting for laparoscopic cholecystectomy may differ as compared to a chronically ill and wasted orthopaedic patient. Further limitations include non-uniformity of ambient operating theatre temperatures, as well as a variation in pharmacotherapy for which data was not collected. This may have influenced the vasodilatory response of patients. Although the principal investigator was present at the start of the procedure, individual participants data was recorded by the attending anaesthetic provider. The Traxit Skin temperature monitor has been designed as a paediatric temperature monitor, the impact of probe size and foot print area on measuring an adult’s temperature is unknown.
Strengths of this study are its prospective nature and pragmatic study design. The large number of data points has allowed sub-analysis of study groups and has yielded meaningful results.
Future research is required to find the most suitable location and device for temperature monitoring in an awake patient where the availability of non-invasive temperature monitors is limited. Temperature monitoring should be compulsory and be emphasized as an important function of the anaesthetic provider.