A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization.

Monitoring product temperature during lyophilization is critical, especially during the process development stage, as the final product may be jeopardized if its process temperature exceeds a threshold value. Also, in-situ temperature monitoring of the product gives the capability of creating an optimized closed-loop lyophilization process. While conventional thermocouples can track product temperature, they are invasive, limited to a single-point measurement, and can significantly alter the freezing and drying behavior of the product in the monitored vial. This work has developed a new methodology that combines non-invasive temperature monitoring and comprehensive modeling. It allows the accurate reconstruction of the complete temperature profile of the product inside the vial during the lyophilization process. The proposed methodology is experimentally validated by combining the sensors' wirelessly collected data with the advanced multiphysics simulations. The flexible wireless multi-point temperature sensing probe is produced using micro-manufacturing techniques and attached outside the vial, allowing for accurate extraction of the product temperature.

Assessment of Non-Contact Infrared Thermometer Measurement Sites in Birds.

The standard method of obtaining body temperature in a bird can be a stressful event, making routine evaluations challenging. Twenty-eight privately owned birds in good health were enrolled in the study to compare digital and infrared (IR) temperature readings. Digital thermometer readings in the cloaca were compared with two different IR thermometers, Ototemp (OT) and VetTemp (VT), used at the skin of the cloaca, breast, axillary area and tympanic membrane. The majority of the IR temperature readings were not significantly different from the cloacal digital reading. Additionally, the different IR thermometers read close to each other at individual reading sites. The IR measurements at the axilla (OT, mean = 40.35°C, SD = 1.24°C; VT, mean = 40.20°C, SD = 1.38°C) were most similar to the standard cloacal measurement (mean = 40.83°C, SD = 0.88°C). For veterinarians who currently avoid measuring cloacal body temperatures to prevent unnecessary stress on avian patients utilizing IR thermometers in the axillary region provide a less invasive and reasonable measurement of core body temperature in birds to allow for a more comprehensive assessment of health status.

Evaluation of Noninvasive Thermometers in an Endoscopy Setting.

The measurement of body temperature is an important aspect of assessment prior to invasive procedures. The purpose of the study was to determine the level of agreement between temporal artery, noncontact infrared, and disposable oral electronic thermometers to a clinical reference device (nondisposable oral electronic thermometer) in outpatients prior to an endoscopic procedure. A descriptive, method-comparison study design was used to compare 3 noninvasive thermometers with a clinical reference device. Four noninvasive temperatures were measured with 3 test devices (temporal artery with ear tap; temporal artery without ear tap; disposable oral electronic; and noncontact infrared), followed by measurement with the clinical reference device (nondisposable, oral electronic). Differences (bias) and limits of agreement (±1.96 SD) were calculated for the test devices and graphed using Bland-Altman method. Clinically acceptable levels of agreement were set at a bias of 0.54 °F or less and precision of 0.90 °F or less. A total of 25 endoscopy patients (N = 14 female; N = 11 male) were studied, with temperatures ranging from 97.5 to 98.9, averaging 98.1 ± 0.3 °F. All thermometers, with the exception of the noncontact infrared (0.66 °F), had acceptable ranges for use in clinical practices. Findings from this study support the use of both temporal artery and disposable oral electronic thermometers in afebrile outpatients but not the noncontact infrared thermometer.

Temperature Measurements: Comparison of Different Thermometer Types for Patients With Cancer.

BACKGROUND: Accurate temperature measurement in patients with cancer is critical. Many patients are neutropenic; therefore, fever represents an oncologic emergency, and, in many cases, it can be the only indication of a life-threatening infection. Although oral thermometers most closely represent true core temperature, patients may have barriers to oral thermometry. OBJECTIVES: The purpose of this study was to assess the accuracy of two alternative, noninvasive thermometers (tympanic and temporal artery) by comparing them to an oral thermometer. METHODS: A method-comparison study design was used. Each participant received three temperature measurements. The dependent variable was the difference in temperature between the test thermometers and the oral thermometer. FINDINGS: The results suggest that neither of the test thermometers accurately represented core temperature, particularly in febrile patients. Both the tympanic and temporal artery thermometers became less accurate as oral temperature increased.

Body temperature measurement in mice during acute illness: implantable temperature transponder versus surface infrared thermometry.

Body temperature is a valuable parameter in determining the wellbeing of laboratory animals. However, using body temperature to refine humane endpoints during acute illness generally lacks comprehensiveness and exposes to inter-observer bias. Here we compared two methods to assess body temperature in mice, namely implanted radio frequency identification (RFID) temperature transponders (method 1) to non-contact infrared thermometry (method 2) in 435 mice for up to 7 days during normothermia and lipopolysaccharide (LPS) endotoxin-induced hypothermia. There was excellent agreement between core and surface temperature as determined by method 1 and 2, respectively, whereas the intra- and inter-subject variation was higher for method 2. Nevertheless, using machine learning algorithms to determine temperature-based endpoints both methods had excellent accuracy in predicting death as an outcome event. Therefore, less expensive and cumbersome non-contact infrared thermometry can serve as a reliable alternative for implantable transponder-based systems for hypothermic responses, although requiring standardization between experimenters.

Digital Axillary and Non-Contact Infrared Thermometers for Children.

Axillary digital thermometers (ADTs) and non-contact (infrared) forehead thermometers (NCIFTs) are commonly used in pediatric settings, where an incorrect body temperature measurement may delay treatments or lead to incorrect diagnoses and therapies. Several studies comparing ADT or NCIFT with other methods have found conflicting results. To investigate whether ADT and NCIFT can be used interchangeably, a comparative observational study was conducted involving 205 children aged 0 to 14 years who were consecutively admitted to the pediatric emergency department. The Bland-Altman plot illustrated agreement between the two methods. A total of 217 pairs of measurements were compared; axillary measurements showed average values significantly higher than forehead measurements (37.52°C and 37.12°C; t = 7.42, p = .000), with a mean difference of 0.41°C between the two methods (range = -1.80 and +2.40). In this setting and population, ADT and NCIFT cannot be used interchangeably.

Effect of orthodontic brackets and different wires on radiofrequency heating and magnetic field interactions during 3-T MRI.

OBJECTIVES: To evaluate the heating and magnetic field interactions of fixed orthodontic appliances with different wires and ligaments in a 3-T MRI environment and to estimate the safety of these orthodontic materials. METHODS: 40 non-carious extracted human maxillary teeth were embedded in polyvinyl chloride boxes, and orthodontic brackets were bonded. Nickel-titanium and stainless steel arch wires, and elastic and stainless steel ligaments were used to obtain four experimental groups in total. Specimens were evaluated at 3 T for radiofrequency heating and magnetic field interactions. Radiofrequency heating was evaluated by placing specimens in a cylindrical plastic container filled with isotonic solution and measuring changes in temperature after T1 weighted axial sequencing and after completion of all sequences. Translational attraction and torque values of specimens were also evaluated. One-way ANOVA test was used to compare continuous variables of temperature change. Significance was set at p < 0.05. RESULTS: None of the groups exhibited excessive heating (highest temperature change: <3.04 °C), with the maximum increase in temperature observed at the end of the T1 weighted axial sequence. Magnetic field interactions changed depending on the material used. Although the brackets presented minor interactions that would not cause movement in situ, nickel-titanium and stainless steel wires presented great interactions that may pose a risk for the patient. CONCLUSIONS: The temperature changes of the specimens were considered to be within acceptable ranges. With regard to magnetic field interactions, brackets can be considered "MR safe"; however, it would be safe to replace the wires before MRI.

Clinical accuracy of tympanic thermometer and noncontact infrared skin thermometer in pediatric practice: an alternative for axillary digital thermometer.

INTRODUCTION: The aim of this study was to compare the body temperature measurements of infrared tympanic and forehead noncontact thermometers with the axillary digital thermometer. METHODS: Randomly selected 50 pediatric patients who were hospitalized in Dr Behcet Uz Children's Training and Research Hospital, Pediatric Infectious Disease Unit, between March 2012 and September 2012 were included in the study. Body temperature measurements were performed using an axillary thermometer (Microlife MT 3001), a tympanic thermometer (Microlife Ear Thermometer IR 100), and a noncontact thermometer (ThermoFlash LX-26). RESULTS: Fifty patients participated in this study. We performed 1639 temperature readings for every method. The average difference between the mean (SD) of both axillary and tympanic temperatures was -0.20°C (0.61°C) (95% confidence interval, -1.41°C to 1.00°C). The average difference between the mean (SD) of both axillary and forehead temperatures was -0.38 (0.55°C) (95% confidence interval, -1.47°C to 0.70°C). The Bland-Altman plot showed that most of the data points were tightly clustered around the zero line of the difference between the 2 temperature readings. With the use of the axillary method as the criterion standard, positive likelihood ratios were 17.9 and 16.5 and negative likelihood ratios were 0.2 and 0.4 for tympanic and forehead measurements, respectively. DISCUSSION: The results demonstrated that the infrared tympanic thermometer could be a good option in the measurement of fever in the pediatric population. The noncontact infrared thermometer is very useful for the screening of fever in the pediatric population, but it must be used with caution because it has a high value of bias.

Temperature measurement in the preterm and term neonate: a review of the literature.

The maintenance of a constant body temperature is important to all humans but even more so for newborn babies (neonates), especially those born pre-term. Because accurate measurement of body temperature is an important component of thermoregulation management in the neonate, a review of the literature was undertaken to determine the most appropriate method and site of temperature measurement in both the preterm and term neonate. The available evidence indicates that the axilla remains the most common place for temperature measurement.

The factors that have a role in variability for temperature.

Our objective was to determine the factors that affect (i) the rectal-axillary temperature measurement difference (RATD) for digital and mercury-in-glass thermometers and (ii) the difference between mercury-in-glass and digital thermometer readings taken by the rectal and axillary routes. Children (between the ages of 2 and 48 months) who were admitted to Hacettepe University Children Hospital and Corum Children's Hospital in 2 months period were included in this study. Two measurements were taken from each patient within 2 days at two different occasions including day/night and sleep/awake by the same physician. A total of 135 patients were enrolled. RATD was 0.61 + 0.54 degrees C in the mercury-in-glass thermometer, and 0.81 +/- 0.57 degrees C in the digital thermometer. The mean differences between digital and mercury-in-glass thermometers were 0.16 degrees C for rectal routes and -0.02 degrees C for axillary routes. Children at older age with hypoalbuminemia and children exposed to higher ambient temperatures had lower values of RATD than others. Temperature recordings from different sites might change with ambient temperature and individual characteristics of children.

Comparing body temperature measurements by mothers and physicians using mercury-in-glass, digital mercury and infrared tympanic membrane thermometers in healthy newborn babies.

While planning medical care, health care workers must consider the body temperature changes as measured by the mothers on most occasions. We evaluated the reliability of three different temperature measurement methods when they were used by the mothers by comparing with the measurements taken by the pediatrician. In this prospective study, body temperatures of 50 healthy newborns during their 2nd day of life were measured by mothers and one physician with mercury-in-glass (MG), digital mercury (DM) and infrared tympanic membrane thermometers (ITMT). Measurements by the mothers and the physician were correlated for the three different methods. The effects of the educational level of the mothers and the presence of children at home on the reliability and the number of differences > or = 0.5 degrees C were also evaluated for each of the methods. In comparing the measurements by the mothers and the pediatrician, correlation coefficient was 0.12 in MG thermometer readings, 0.23 in DM thermometer readings and 0.78 in ITMT readings, meaning that tympanic measurements by the mothers and the pediatricians were more correlated (p < 0.0001). The means and ranges of absolute differences of MG, DM, and tympanic thermometer measurements were 0.43 +/- 0.42, 0-1.7; 0.36 +/- 0.45, 0-2.2; and 0.13 +/- 0.12, 0-0.7 degrees C, respectively. The number of measurements with an absolute difference > or = 0.5 degrees C was 17 in MG readings, 11 in DM readings, and 1 in ITMT readings, The educational level of the mothers and the presence of children at home had no effect on the correlations. The intraclass coefficient for the three sets of measurements by the pediatricians was 0.91. Body temperature measurements in newborn babies as taken by their mothers were more correlated with the readings by the pediatricians when the ITMT was used. Tympanic thermometers seem to be useful for the mothers of any educational level and are independent of having experience with a previous child. The ease of use and short calibration time for reading are also advantageous for these thermometers.

Measuring the body temperature: how accurate is the Tempa Dot?

INTRODUCTION: We evaluated the accuracy of a disposable, sterile thermometer that is practical in use and holds no risk of cross-infections. METHODS: a cross-sectional study was set up in which we compared the Tempa Dot with the mercury thermometer in adults and children. Subjects were recruited from general practice and a paediatric ward. The mercury thermometer was used orally in subjects over 2 years of age and rectally in children up to 2 years old. The Tempa Dot was used either orally or axillary. RESULTS: The total population consisted of 212 patients, of which 131 children were younger than 16 years old. Their mean age was 17.3 years old, ranging from 1 month to 76 years. The mean difference between the mercury thermometer and the Tempa Dot, used orally or axillary, was 0.04 degrees C. For children between 0 and 16 years old, the mean difference was 0.08 degrees C. Agreement between the two methods as assessed with regression analysis and Bland and Altman plots was very good. ROC curve analysis suggests cut-off points of 37.2 and 37.6 degrees C to detect fever for the Tempa Dot at the oral and the axillary site respectively. Sensitivity and specificity were 100.0% and 79.0% for the total population, measuring orally and 100.0% and 95.9% axillary. In children, sensitivity and specificity were 100.0% and 83.1% orally, and 100.0% and 95.4% axillary. Using a single cut-off point for both measuring sites, namely 37.5 degrees C, sensitivity dropped and specificity increased for the oral site. For the axillary site, sensitivity remained unchanged and specificity was somewhat less. CONCLUSION: the Tempa Dot is a reliable alternative for the mercury thermometer. In clinical use, a cut-off point of 37.5 degrees C for both the oral and axillary site is most appropriate.

Temperature measurement: comparison of non-invasive methods used in adult critical care.

AIMS AND OBJECTIVES: To assess accuracy and reliability of two non-invasive methods, the chemical (Tempa.DOT) and tympanic thermometer (Genius First Temp M3000A), against the gold standard pulmonary artery catheter, and to determine the clinical significance of any temperature discrepancy using an expert panel. BACKGROUND: There is continued debate surrounding the use of tympanic thermometry in clinical practice. DESIGN: Prospective study. METHODS: A total of 160 temperature sets were obtained from 25 adult intensive care patients over a 6-month period. RESULTS: About 75.2% (n = 115) of chemical and 50.9% (n = 78) of tympanic readings were within a +/-0.0-0.4 degrees C range of the pulmonary artery catheter. Both the chemical and tympanic thermometers were significantly correlated with temperatures derived from the pulmonary artery catheter (r = 0.81, P < 0.0001 and r = 0.59, P < 0.0001) and limits of agreement were -0.5-0.9 degrees C and -1.2-1.2 degrees C respectively. The chemical thermometer was associated with a mean temperature difference of 0.2 degrees C, which increased 0.4 degrees C when used in conjunction with a warming blanket. With regard to clinical significance 15.3% (n = 26) of chemical and 21.1% (n = 35) of tympanic readings might have resulted in patients receiving delayed interventions. Conversely 28.8% (n = 44) of chemical and 37.8% (n = 58) of tympanic readings might have resulted in patients receiving unnecessary interventions. CONCLUSIONS: The chemical thermometer was more accurate, reliable and associated with fewer clinically significant temperature differences compared with the tympanic thermometer. However, compared with the pulmonary artery catheter both methods were associated with erroneous readings. In the light of these findings and previous research evidence, it is becoming increasingly difficult to defend the continued use of tympanic thermometry in clinical practice. However, as chemical thermometers are not without their limitations, further research needs to be undertaken to evaluate the accuracy and reliability of other non-invasive methods. RELEVANCE TO CLINICAL PRACTICE: Chemical and tympanic thermometers are used in both adults and children in a wide variety of settings ranging from community to intensive care. As such these findings have significant implications for patients, users and budget holders.

Body temperature regulation during hemodialysis in long-term patients: is it time to change dialysate temperature prescription?

During hemodialysis procedures, changes in the dialysate temperature can raise or lower body temperature because the blood is returned to the patient in thermal equilibrium with the dialysate. Even a dialysate temperature equal to the patient's body temperature as measured from the tympanic membrane, oral cavity, or axilla can result in an increase in the patient's body temperature, leading to cutaneous vasodilation and the potential for cardiovascular instability and hypotension. This deleterious cycle of events can be prevented by suitably adjusting the dialysate temperature. Lowering the dialysate temperature from 37 degrees C to 34-35.5 degrees C has improved the cardiovascular stability of many hemodialysis patients. Continuous monitoring of blood temperature allows the practitioner to make preemptive changes in dialysate temperature because a small change in body temperature can have enormous cardiovascular implications. For example, only 0.3 degrees C to 0.8 degrees C separates the thresholds for skin vasodilation from that for shivering. A suggested improvement in the hemodialysis procedure is to use devices that allow continuous monitoring of arterial and venous blood temperatures and adjust the dialysate temperature automatically, keeping the patient, not the dialysate, isothermic. Less optimal solutions appear to be (1) to monitor arterial and venous temperatures while manually adjusting the dialysate temperature to maintain arterial (and hence body) temperature stability; (2) to monitor peripheral temperatures (oral, tympanic) at regular intervals and adjust dialysate temperature to maintain the body temperature constant; (3) routinely use a dialysate temperature <37.0 degrees C in all patients unless contraindicated.

El termómetro clínico, un hito en la historia de la medicina / Termometro, a landmark in the history of the medicine

Los hombres queremos conocer la naturaleza para dominarla, obtener de ella el máximo beneficio, y satisfacer nuestras necesidades, la inventiva humana ha logrado dar saltos importantes determinando el progreso tecnológico. el bienstar humano ha sido la mayor preocupacióm y hubieron numerosos e insignes hombres de cencia, que dedicaron su vida y conocimientos en busca de devolver la salud, he aquí un ejemplo de cómo estos científicos lograron crear un instrumento valioso, como es el termómetro y su aplicación en la medicina, para bien de la humanidad. El presente trabajo de investigación comprende dos momnetos, por una parte el desarrollo evolutivo del termómetro en general que comprende el contexto histórico y por otra parte el marco teórico que trata del origen y evolución en la aplicaicón de este instrumento en medicina, como método diagnóstico de las enfermedades, que sin duda alguna , constituye un hito en la historia de la medicina y un gran aporte ala ciencia. Este trabajo sin emabrgo no pretende descubrir los descubierto, pero intenta ubicar los momentos históricos por los cuales tuvo que transitar la invención de este instrumento de medición diaria de la temperatura como método científico, de ahí que apoyado en la documentación histoórica, se utilizo el método investigativo, así como el explicativo e ilustrativo. apoyado en la lógica de la investigación y motivado por la significación que constituye el termómetro en la práctica médica, inicio este trabajo titulado: "El termómetro clínico en el registro de la temperatura: un hito en la historia de la medicina".Problema: necesidad de conocer el momento histórico de la invención y aplicación de un instrumento que permitió el diagnóstico clínico y registro de la temperatura corporal en el proceso salud enfermedad. Objeto: Signos y síntomas del proceso salud enfermedad. Campo de acción: Diagnóstico dínico y registro de la temperatura corporal. Objetivo. Establecer el hecho histórico de la invención y aplicación del termómetro en el diagnóstico clínico y e registro de la temperatura corporal.

[Systems for the determination of body temperature]. / Sistemas para determinar la temperatura corporal.

It is essential for a health care professional to know how body temperature is regulated, what factors affect body temperature, and what different measurement systems are available. This file contains descriptions of 1) the thermometers available: electronic, mercury-based, infrared; 2) the places where body temperature can be measured: skin, armpits, rectum, mouth, tympanum, esophagus, or pulmonary artery blood. All content material is justified by a documented bibliography.