Evaluation of temporal artery and disposable digital oral thermometers in acutely ill patients.
Invasive measures of core body temperature, such as thermistors implanted on the tip of intravascular catheters, provide the most accurate temperature in acutely ill patients (Bridges & Thomas, 2009; Hooper & Andrews, 2006). With increasing emphasis on cost containment and elimination of hospital-acquired blood and urinary tract infections (Gould et al., 2010; Marschall et al., 2008; Yokoe, 2008), invasive methods for temperature monitoring are no longer the norm in hospitalized patients (Forbes, 2009; Hooper & Andrews, 2006; Sessler, 2008). When invasive methods for temperature measurement are not available, clinicians often measure temperature by one of the following noninvasive methods: oral, axillary, tympanic, or the relatively new temporary artery (forehead) device.
Review of the literature included searches of Pubmed and CINAHL databases for years 1980-2014. Search terms included the following: thermometer accuracy, noninvasive thermometer, noninvasive temperature, oral electronic thermometer, and temporal artery thermometer. Selected literature was restricted to studies that evaluated agreement between temporal artery thermometers and either noninvasive or invasive reference standard temperature devices.
Prior literature has indicated the most accurate noninvasive method for temperature measurement in adults is an oral temperature obtained with an electronic, nondisposable thermometer (Bridges & Thomas, 2009; Forbes, 2009; Hooper & Andrews, 2006). Oral temperatures obtained with an electronic nondisposable thermometer approximate core temperatures closely (esophageal and pulmonary artery) (Erickson & Kirklin, 1993; Fallis, Gupton, & Kassum, 1994; Giuliano, Scott, Elliot, & Giuliano, 1999; Giuliano et al., 2000; Lawson et al., 2007; Schmitz, Bair, Falk, & Levine, 1995; Smith, 2004) and have been used previously as the reference standard in temperature studies when an invasive measurement of core temperature is not feasible (Fountain et al., 2008; Frommelt, Ott, & Hays, 2008; Hutton et al., 2009). Multiple study findings have led to the recommendation that tympanic thermometers not be used routinely in pediatric or adult acute care due to poor agreement with reference standard temperature devices (Bridges & Thomas, 2009; Craig, Lancaster, Taylor, Williamson, & Smyth, 2002; Dew, 2010; Dodd, Lancaster, Craig, Smyth, & Williamson, 2006; Erickson & Meyer, 1994; Moran et al., 2007).
As one of many strategies aimed at decreasing hospital-acquired infections, some institutions now use disposable equipment for assessment of vital signs, including digital disposable oral thermometers. Despite the device's use in some acute care settings, no published clinical studies have been found on the accuracy of disposable digital thermometers in hospitalized patients. Clinicians have accepted these devices as equivalent to nondisposable oral devices without evidence to support that judgment.
Another relatively new temperature device is the temporal artery thermometer. Using the same type of technology as the tympanic thermometer, this device measures temperature by moving the temperature probe across the forehead and then placing it briefly behind the ear. Limited clinical studies in adults have been performed on this new device (Fountain et al., 2008; Frommelt et al., 2008; Hutton et al., 2009; Langham et al., 2009; Lawson et al., 2007; Myny, DeWaele, Defloor, Blot, & Colardyn, 2005; Suleman, Doufas, Akca, Ducharme, & Sessler, 2002), some of which had methodologic flaws that limit the generalizability of their findings (e.g., poorly described and/or inappropriate methods) (Langham et al., 2009; Myny et al., 2005; Suleman et al., 2002). Additional research is needed to determine if this method for noninvasive temperature assessment is an acceptable substitute for oral temperatures in hospitalized patients.
The purpose of this study was to determine the level of agreement between the oral nondisposable electronic thermometer (reference standard device) and two test thermometers (digital disposable oral thermometer and temporal artery thermometer) in acutely ill patients.
Materials and Methods
This study was conducted on a 30-bed medical-surgical intensive care unit in a 421-bed community hospital in the southeastern United States. Study approval was obtained from the institution's investigational review board prior to data collection. Data were collected over a 2-month period in 2010.
A method-comparison study design was used to compare different methods of temperature measurement. Each subject served as his or her control. The primary outcome variable was the difference in temperatures obtained with the test devices (digital disposable oral; temporal artery) and the reference standard device (nondisposable oral electronic). The electronic nondisposable oral temperature device served as the reference thermometer because invasive temperature devices were not used routinely in the study institution. The oral electronic thermometer has been shown previously to provide results similar to core temperatures (Giuliano et al., 2000; Lawson et al., 2007; Schmitz et al., 1995; Smith, 2004) and has been used in other temperature studies as the reference standard when invasive core measures were not available or inappropriate (Fountain et al., 2008; Frommelt et al., 2008; Hutton et al., 2009).
Acceptable values for agreement between the test and reference standard devices were established a priori based on experts' recommendations (bias [less than or equal to] [+ or -] 0.3[degrees]C; precision [less than or equal to] [+ or -] 0.5[degrees]C) (Bridges & Thomas, 2009; Forbes, 2009; Giuliano et al., 2000; Lawson et al., 2007; Sessler, 2008). Order of test temperature measurement was assigned randomly by a computer-generated number sequencer.
Subjects for this study were a convenience sample of acutely ill patients requiring temperature measurement. Criteria for study inclusion were age 18 or older and physiologic stability (<10% variation in heart rate, blood pressure, respiratory rate, temperature, and oxygen saturation within the past hour). Criteria for study exclusion were prisoners; pregnancy; physical impediments to proper use of any temperature devices; ingestion of hot or cold oral fluids 30 minutes prior to data collection; and/or abrasions, scars, or open sores on the forehead or skin in the temporal area.
A minimum sample size of 47 was determined a priori with power analysis, using a power of 0.8, an alpha level of 0.05, and an effect size of 0.50 (Cohen, 1977; Mayer, Buchner, Faul, & Erdfleder, 2007). Effect size (ES) was calculated using a standard ES formula [ES = ([mean.sub.groupA] - [mean.sub.groupB])/SD] and was based on clinical judgment and expert opinion (Bridges & Thomas, 2009; Forbes, 2009; Giuliano et al., 2000; Lawson et al., 2007; Sessler, 2008) that differences between the test temperature devices (disposable oral electronic; temporal artery) and the nondisposable oral electronic reference temperature of > [+ or -] 0.32[degrees]C would limit the clinical utility of that device for temperature measurement and clinical decision making surrounding temperature management. Standard deviation data for the sample size calculation were based on prior research (Lawson et al., 2007).
The following instruments were used in the study according to manufacturers' directions:
1. Nondisposable oral electronic thermometer (reference standard): Sure Temp Plus electronic thermometer (Welch Allyn, Skaneateles Fall, NY). Manufacturer's specifications include a clinical accuracy of [+ or -] 0.1[degrees]C for temperatures 26.7[degrees]-43.5[degrees]C.
2. Disposable digital oral electronic thermometer (test device): Medichoice (Mesure Technology Co, Wuxi City, Jiangsu Province, China). Manufacturer's specifications include a clinical accuracy of [+ or -] 0.1 C for temperatures 34.6[degrees]-38.9[degrees]C.
3. Temporal artery thermometer (test device): Model TAT-500 temporal artery thermometer (Exergen Corp, Watertown, MA). Manufacturer's specifications include a clinical accuracy of [+ or -] 0.1[degrees]C for temperatures 34.5[degrees]-43[degrees]C.
The nondisposable temperature devices were calibrated by biomedical engineering staff prior to data collection and dedicated for study use only. Calibration of digital, disposable oral thermometers was not possible because they are single use, disposable thermometers. Only study investigators performed data collection; all of them were experienced acute care registered nurses trained in correct device use prior to enrollment of participants. Validation of correct use and consistency of temperatures obtained between investigators was established in a training session as follows: each investigator performed temperature measurement with a given device until temperature measurements were within 0.1[degrees]C with sequential temperature measurement and when obtained by a second trained investigator for the same patient immediately after the first investigator.
At the time of a regularly scheduled measurement, temperatures were obtained with the three different devices once within a 3-minute period with the patient in the same body position. Order of device use was assigned randomly for all devices except the reference standard device (nondisposable oral electronic), which was always obtained last. Obtaining the reference standard temperature last was done to prevent any investigator bias from influencing test device measurements.
All devices were used in accordance with manufacturers' directions. Oral temperature devices were inserted into the mouth and held in the posterior sublingual pocket. In subjects with endotracheal tubes in situ, the sublingual pocket opposite to the tube was used for temperature measurement. Temporal artery temperatures were obtained by moving the temperature probe across the forehead to the hairline over the temporal artery area and then placing the probe briefly behind the ear. The electronic nondisposable oral thermometer was used in the monitor mode.
Data were summarized using descriptive statistics. Chi-square analysis was used to test for differences between devices in the number of temperatures equal to or greater than [+ or -] 0.5[degrees] or greater than or equal to + 1.0[degrees]C different from the reference standard temperatures. The level of significance for statistical tests was p<0.05.
Differences (bias), standard deviation (precision), and limits of agreement ([+ or -] 2 SD) between the test and reference standard temperature devices were calculated using standard formulas and graphed using the Bland-Altman method (Bland & Altman, 1986, 1995; Chatburn, 1996; Hanneman, 2008; Szaflarski & Slaughter, 1996). This type of graphing allows the extent of the agreement between two medical devices to be clearly visible. The graphs also allow rapid assessment of data linearity across the range of studied temperatures.
Forty-eight acutely ill patients were studied over a 2-month period. Varied patient diagnoses represented both medical and surgical conditions. Average age (+ SD) of participants was 64.3 [+ or -] 14.8 years, with men representing the majority of participants (n=26, 54%). Temperatures ranged from 35.4[degrees]to 39.1[degrees] C. Temperatures of 38.0[degrees]C or higher occurred in 4 of the 48 (8%) participants, with temperatures of less than 36.0[degrees]C in 7 of 48 participants (15%).
[FIGURE 1 OMITTED]
Temperature means and differences between the test devices and the reference standard temperature device (electronic nondisposable oral) are summarized in Table 1 and displayed in Figures 1 and 2. Bias and precision values were -0.26[degrees] [+ or -] 0.56[degrees]C for the digital disposable oral device and 0.44[degrees] [+ or -] 0.60[degrees] for the temporal artery device. Bland-Altman graphs showed uniform differences between the reference standard device and the digital oral disposable (see Figure 1) and temporal artery (see Figure 2) thermometer devices across the range of temperatures measured.
The number of temperature differences greater than [+ or -] 0.5[degrees] and greater than or equal to [+ or -] 1.0[degrees]C between the test and reference standard devices were 21% and 13%, respectively, for the digital oral disposable thermometer and 44% and 21%, respectively, for the temporal artery thermometer (see Table 1). The digital oral disposable thermometer had significantly fewer instances of temperature differences greater than [+ or -] 0.5[degrees]C than the temporal artery thermometer (Chi square=5.77, p=0.02). No statistical differences were found in the number of temperature differences greater than or equal to [+ or -] 1.0[degrees]C between the digital oral disposable and temporal artery thermometer (Chi square=1.20, p=0.21).
Digital Disposable Oral Thermometer Accuracy
With increasing use of disposable equipment in hospitals as an approach to decrease hospital-acquired infection rates, nurses must determine if disposable equipment meets recommended accuracy levels. The current study appears to be the first clinical study to evaluate use of the digital disposable oral thermometer in acutely ill patients. Prior studies of disposable oral thermometers evaluated a plastic chemically impregnated, heat-sensitive strip with temperature indicator dots on the end (Tempa-DOTs[TM], 3M Health Care, St. Paul, MN) (Erickson, Meyers, & Woo, 1996; Fallis et al., 1994; Fountain et al., 2008; Frommelt et al., 2008; Hutton et al., 2009). The digital disposable oral thermometer evaluated in this study had an acceptable bias value (0.26[degrees]C lower than the nondisposable oral electronic thermometer), but a precision value ([+ or -] 0.56[degrees]C) that slightly exceeded the recommended value ([+ or -] 0.5[degrees]C). The fact that the precision of the disposable device exceeded recommended values is reinforced by the number of temperature differences greater than or equal to [+ or -] 0.5[degrees]C (21%, or 1 of 5 temperatures measured).
[FIGURE 2 OMITTED]
The disposable device was easy to use and allowed ready visualization of the final temperature value. The digital temperature display was unambiguous, in contrast to reports of visualization difficulties with the heat-sensitive disposable temperature strips (Tempa-DOTs) (Creagh-Brown, James, & Jackson, 2005; Frommelt et al., 2008). Easy visualization is particularly important when a device is being used in a busy practice environment with variable lighting conditions, as may be found in patient rooms.
Additional studies are needed to validate these findings, particularly in hypothermic and febrile patients. The results, however, indicate the digital disposable oral temperature device exceeded experts' recommendations for clinical acceptability as a replacement for the electronic nondisposable oral thermometer. Based on the results of this study, routine clinical use of this device is not recommended until additional studies are done.
Temporal Artery Thermometer Accuracy
Although oral temperature measurement with an electronic nondisposable thermometer is considered the most accurate way for noninvasive temperature measurement in adults (Bridges & Thomas, 2009; Hooper & Andrews, 2006), a number of clinical conditions and situations limit the use of this route for temperature monitoring (e.g., oral surgery, oral or facial trauma, uncooperative patients). Because axillary and tympanic noninvasive temperature routes have not been recommended by most experts as an acceptable replacement for invasive core measures (Bridges & Thomas, 2009; Craig et al., 2002; Dew, 2010; Dodd et al., 2006; Erickson & Meyer, 1994; Hooper & Andrews, 2006; Moran et al., 2007), the recent introduction of the temporal artery thermometer presented another potential noninvasive route to use in place of the oral route. Temporal artery thermometers, infrared devices with similar technology to the tympanic thermometer, measure temperature frequently while a probe is moved across the forehead to the area over the temporal artery and then moved behind the ear for final temperature calculation.
Results from this study found both the bias and precision values of the temporal artery device (0.44[degrees] [+ or -] 0.66[degrees]C, respectively) to exceed recommendations for clinical acceptability to use the device as a replacement for the electronic nondisposable oral thermometer (bias [less than or equal to] [+ or -] 0.3[degrees]C; precision [less than or equal to] [+ or -] 0.5[degrees]C) (Bridges & Thomas, 2009; Forbes, 2009; Giuliano et al., 2000; Fawson et al., 2007; Sessler, 2008). This device also had a large number of temperatures that were greater than [+ or -] 0.5[degrees]C from the reference standard device (44%), with 21% of temperatures greater than or equal to [+ or -] 1.0[degrees]C. While three of five prior studies in adults found bias values to be acceptable with the temporal artery device, all had precision values that reached or exceeded the upper level of acceptability ([less than or equal to] [+ or -] 0.5[degrees]C) (Fountain et al., 2008; Frommelt et al., 2008; Hutton et al., 2009; Lawson et al., 2007; Suleman et al., 2002).
Based on current results as well as precision values found in prior studies, routine use of the temporal artery thermometer for temperature monitoring in acutely ill patients is not recommended at this time. Use should be restricted to situations when invasive temperatures and noninvasive oral temperatures are contraindicated (e.g., infection risk, oral trauma). Because of the large number of discrepancies between the temporal artery and electronic nondisposable oral thermometers, clinicians should use caution when evaluating individual temperatures if using this device.
As is true with all medical device studies, devices should be tested under normal and abnormal physiologic ranges typically observed in clinical practice (Hanneman, 2008; Szaflarski & Slaughter, 1996). Similar to many prior temperature device accuracy studies, this study had very few patients with abnormal temperatures. Additional studies are needed of the performance of all temperature devices used in clinical practice in patients with abnormal temperatures because the level of agreement may be different in the extreme ranges of measured values. Additional studies also are needed of other digital disposable oral thermometers because results may vary with different models or manufacturers of these devices. Another limitation of this study was the inability to verify the calibration of each digital disposable oral device before or after temperature measurement in each subject.
Clinicians often have a need to use different types of thermometers in practice because clinical conditions may limit the use of common thermometers. Based on the results of this study, clinicians should not assume temperatures obtained with the temporal artery thermometer or the specific brand of disposable oral thermometer used in this study are equivalent to what would be obtained with a nondisposable oral electronic thermometer.
Both the digital disposable oral and temporal artery thermometers had precision values which exceeded expert recommendations ([less than or equal to] 0.5[degrees]C) for use of the devices as equivalent to reference standard devices. Neither of the studied devices is recommended as a routine replacement for the electronic nondisposable oral thermometer for noninvasive temperature monitoring in acutely ill patients. Clinicians should use caution when interpreting temperatures from these devices used for acutely ill patients.
Acknowledgments: Special thanks to Marianne Chulay, PhD, RN, FAAN, for assistance with study design, data analysis, and manuscript preparation.
Limited data are available on the bias and precision of digital disposable oral thermometers and temporal artery thermometers.
This study was conducted to determine the level of agreement between noninvasive methods for temperature measurement in acutely ill patients.
A method-comparison study design was used to examine the agreement between two different noninvasive temperature devices (digital disposable oral thermometer; temporal artery thermometer) and a reference standard device (electronic, nondisposable oral thermometer). Temperatures were taken once with all devices in a convenience sample of acutely ill patients. Bias and precision were calculated and graphed with the Bland Altman method to determine the level of agreement between the test devices and the reference standard device. Criteria for device acceptability were set a priori at bias [less than or equal to] [+ or -] 0.3[degrees]C and precision [less than or equal to] [+ or -] 0.5[degrees]C.
Over a 2-month period, acutely ill patients were studied. Bias and precision values were -0.26[degrees] [+ or -] 0.56[degrees]C for the digital disposable oral device and 0.44[degrees] [+ or -] 0.60[degrees] for the temporal artery device. A priori device acceptability criteria were exceeded with both devices.
Both the digital disposable oral and temporal artery thermometers had precision values that exceeded expert recommendations (s [+ or -] 0.5[degrees]C) for use of the devices as equivalent to a reference standard device. Neither of the devices studied is recommended as a routine replacement for the electronic, nondisposable oral thermometer for noninvasive temperature monitoring in acutely ill patients.
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Diane Counts, RN, CCRN, is Clinical RN III, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Mary Acosta, RN, is Staff Nurse, Intensive Care Unit, Munroe Regional Medical Center Ocala FL.
Holly Holbrook, BSN, RN, is Staff Nurse, Surgical Admissions Unit, Munroe Regional Medical Center, Ocala, FL.
Eileen Foos, BSN, RN, CCRN, is Staff Nurse, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Kimberly Hays-Ponder, BSN, RN, is Clinical RN III, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Olga Macairan, BSN, RN, is Staff Nurse, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Linda Thomas, RN, CCRN, is Staff Nurse, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Maryse Whitsett, RN, is Staff Nurse, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Lori Williams, BSN, RN, CCRN, is Clinical RN III, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
Elizabeth J. Twiss, MSN, RN, CCRN, is Nurse Specialist, Intensive Care Unit, Munroe Regional Medical Center, Ocala, FL.
TABLE 1. Mean Temperature, Bias and Precision, and Temperature Differences Greater than [+ or -] 0.5[degrees] and 1.0[degrees]C for Test Temperature Devices and the Electronic Nondisposable Oral Temperature Device in 48 Acutely III Patients Mean Test Device - Temperature Nondisposable Oral [+ or -] SD Temperature * Electronic 36.8 [+ or -] 0.8 Nondisposable Oral Digital 36.5 [+ or -] 1.0 -0.26 [+ or -] 0.56 Disposable Oral Temporal Artery 37.2 [+ or -] 0.8 0.44 [+ or -] 0.60 Number Number Temperature Temperature Differences > Differences > [+ or -] 0.5[degrees]C [+ or -] 1.0[degrees]C Electronic Nondisposable Oral Digital 10 (21%) 6 (13%) Disposable Oral Temporal Artery 21 (44%) 10 (21%) Bias [+ or -] Precision. Bias values s [+ or -] 0.3[degrees]C and precision values s [+ or -] 0.5[degrees]C are within the experts recommended range for clinically acceptable equivalency with the electronic, nondisposable oral thermometer (Bridges & Thomas, 2009; Forbes, 2009; Giuliano et al., 2000; Sessler, 2008).
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|Title Annotation:||Research for Practice|
|Author:||Counts, Diane; Acosta, Mary; Holbrook, Holly; Foos, Eileen; Hays-Ponder, Kimberly; Macairan, Olga; T|
|Date:||Jul 1, 2014|
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