The effectiveness of lying surfaces in nursing care beds, a comparison of spring element systems versus conventional systems: A post marketing clinical follow-up pilot study.

BACKGROUND: Reduced mobility is a strong risk factor for pressure ulcer development in a nursing home setting. Despite this, there is a surprising lack of data regarding suitable nursing care beds in general and the prevention of pressure ulcers provided by lying surface systems in particular. In this context we aimed to assess the mobility of patients using lying surface systems either with spring elements (SES) and to compare these to conventional systems (CS; wooden slats or steel bars). METHODS: This was a prospective, randomized, controlled study in 29 patients with an age range of 54-95 years. Patients were randomly assigned to SES (n = 15) or CS (n = 14). The primary objective was to show a statistically significant difference in the proportion of patients with normal (up to 4 movements per hour) movements as evaluated by the Mobility Monitor®. Pressure distribution of the lying body weight was measured by a full body pressure mapping system XSensor®. Comfort, possibility of movement and recovery of sleep as well as pain at rest were self-rated. RESULTS: We screened a total of 39 patients of which 29 were eligible to be randomized into the two groups and 27 were finally analysed (SES = 14; CS = 13). The mean age was 81.7 ±â€¯9.5 years, 81.5% were female and the mean Braden Scale Score 22.4 ±â€¯1.3. We observed no statistically significant difference in the primary evaluation criterion (proportion of patients with a normal number of movements across 14 nights) between the SES group (81.4 ±â€¯10.8%) and the CS group (72.9 ±â€¯16.3%; p = 0.0757). There was a consistent trend for more movements in the normal range in the SES group however, which was observed when the number of hours with normal movement was plotted per night (p = 0.0004). Measured pressure values showed overall higher values for the lateral compared to the dorsal position with the SES but not the CS forming a "shoulder" between 35-55 mmHg in the dorsal position and between 35-45 mmHg in the lateral position. Self-rated comfort was significantly higher with the SES after night 14 (p = 0.0192) than with CS. CONCLUSIONS: The study is not aimed at the hard endpoint pressure ulcer, but at the physiological movement profile of patients in bed, which justifies a much smaller number of cases. For elderly nursing home patients it appears that beds with spring elements may be associated with higher normality of body movements and higher self-rated comfort. The presented study could be a contribution to reduce the care dependency of patients regarding mobility.

Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

The purpose of the study was to validate the ambulatory blood pressure monitoring (ABPM) device custo screen pediatric in children aged 3 to 12 years according to the International Protocol of the European Society of Hypertension (ESH-IP revision 2010). Thirty-three children were included and systolic and diastolic blood pressure measurements were performed according to the ESH-IP. The protocol was modified for children considering data from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS). The custo screen pediatric met all the requirements of the ESH-IP. The mean difference between the test device and the reference was -1.4 ± 3.0 mmHg for systolic blood pressure (SBP) and -0.7 ± 3.2 mmHg for diastolic blood pressure (DBP). For SBP and DBP, all 99 measurements were within the absolute difference of 10 mmHg between the test device and the reference. As to part 2 of the protocol, for DBP in all subjects, two out of three measurements were within 5 mmHg between the device and the standard, whereas for SBP in 32 of 33 subjects, two out of three measurements were within this range. CONCLUSION: The custo screen pediatric met all criteria of the ESH-IP review 2010, modified for children from 3 to about 12 years, and can be recommended for ABPM in children. What is Known: • Validation of blood pressure measuring devices is essential to provide patients with an accurate blood pressure measuring device. • The majority of devices has not been validated in children. What is New: • Prior to the present validation, study protocol adjustments of ESH-IP review 2010 for children were defined according to German Health Interview and Examination Survey for Children and Adolescents 2013 (KIGGS). • The custo screen pediatric test device met all criteria of ESH-IP revision 2010, modified for children, and can be recommended for ABPM in children aged 3 to about 12 years.

Efficacy of a benzocaine lozenge in the treatment of uncomplicated sore throat.

Benzocaine lozenges are popular in symptomatic treatment of acute sore throat. The aim of this study was to evaluate if sucking a benzocaine lozenge was superior to a placebo lozenge in patients with pain while swallowing. Volunteers with acute, uncomplicated sore throat received randomly and double-blind either a benzocaine 8 mg or a placebo lozenge. Pain was assessed on a numerical visual rating scale. The primary outcome measure was the sum of the pain intensity differences (SPID) over 2 h. Secondary outcome measures included the number of patients who reported 50% or more of their baseline pain score (responders) and those with worthwhile and complete pain relief, the times to worthwhile/complete pain relief and to pain recurrence and the occurrence of any adverse effects. A predefined interim analysis after including 50 patients revealed the superiority of benzocaine versus placebo in the SPID (p = 0.0086). At this time, a total of 165 patients had been recruited (full analysis set, FAS) and underwent statistical analysis. In the FAS, median SPID had significantly more decreased in patients receiving benzocaine compared to placebo (-12 vs. - 5, p = 0.001). There were significantly more responders and patients with worthwhile pain relief in group benzocaine. The number of patients with complete pain relief was very small. Median time to worthwhile pain relief was 20 min (benzocaine) and >45 min (placebo). Adverse events were not observed. Benzocaine lozenges are superior to placebo lozenges and a useful, well-tolerated treatment option to reduce painful pharyngeal discomfort.

Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol.

OBJECTIVE: Aim of this study was to validate the Microlife BP B3 AFIB/enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060-2:2019 in adolescents and adults from a general population. METHODS: BP measurements on the upper arm were performed in 85 subjects (age range 12-88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer. RESULTS: A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and -0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and -0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg). CONCLUSION: The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 protocol and can be recommended for home BP measurements in adolescents and adults.

Validation of the blood pressure measurement device Beurer BM 28 according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The aim of the present study was to validate the blood pressure (BP) monitor Beurer BM 28 according to the International Protocol of the European Society of Hypertension (ESH-IP) revision 2010. METHODS: In 33 subjects of age 27-81 years, BP measurements were performed according to the ESH-IP protocol, which alternates reference mercury sphygmomanometer and device-under-test (Beurer BM 28) measurements, resulting in a total of 99 comparisons. RESULTS: As to part 1 of the protocol, an absolute difference within 5 mmHg between the Beurer BM 28 and the test device was found in 83 out of 99 comparisons for the SBP and 82 out of 99 comparisons for the DBP. In 95 out of 99 SBP comparisons and 96 out of 99 DBP comparisons, the difference was found to be within 10 mmHg, whereas only one outlier was noted with an SBP difference higher than 15 mmHg. Mean difference between the test device and the reference was 0.4 ± 4.4 mmHg for SBP, and 0.5 ± 4.3 mmHg for DBP. According to part 2 of the protocol, 30 out of 33 subjects for SBP, and 28 out of 33 for DBP had a minimum of two out of three comparisons staying within the range of 5 mmHg. In none of the subjects, all three comparisons stayed outside the 5 mmHg absolute difference, while in three subjects this was the case for the DBP. CONCLUSION: The Beurer BM 28 met all requirements of the ESH-IP revision 2010 and can be recommended for BP measurements in the study population under investigation.

Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

OBJECTIVE: The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol. PATIENTS AND METHODS: In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis. RESULTS: The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol. CONCLUSION: The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.

Validation protocols for blood pressure-measuring devices: status quo and development needs.

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

Validation of the blood pressure measurement device Erkameter 125 PRO according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The aim of the present study was to validate the blood pressure (BP) measurement device Erkameter 125 PRO according to the International Protocol revision 2010 of the European Society of Hypertension (ESH-IP2). PATIENTS AND METHODS: In 33 patients aged 32-79 years, BP measurements were performed alternately using the Erkameter 125 PRO and the reference mercury sphygmomanometer according to ESH-IP revision 2010. For the analysis, a total of 99 comparisons were included. RESULTS: All absolute differences between the test device and the reference were within 10 mmHg for systolic blood pressure (SBP), and all except one for diastolic blood pressure (DBP). A total of 93 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 92 out of 99 for DBP. The mean±SD difference between the Erkameter 125 PRO and the standard reference was -0.5±3.5 mmHg for SBP and 0.5±3.5 mmHg for DBP. As to part 2 of ESH-IP 2010, all patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 patients for DBP. CONCLUSION: The Erkameter 125 PRO fulfilled the requirements of parts 1 and 2 of the ESH-IP revision 2010 and can be recommended for office BP measurements in adults.

Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours. MATERIALS AND METHODS: Systolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. RESULTS: The custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was -0.5±4.5 mmHg for SBP and -0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP. CONCLUSION: The custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.

Comparison of the Omron RS6 wrist blood pressure monitor with the positioning sensor on or off with a standard mercury sphygmomanometer.

OBJECTIVE: The aim of the present study was to evaluate the measurement accuracy of Omron RS6 with positioning sensor on (PSON) in comparison with Omron RS6 with positioning sensor off (PSOFF). The Omron RS6 has passed the 2010 version of the European Society of Hypertension International Protocol previously. METHODS: A total of 85 adult participants (39 male and 46 female) were recruited. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured using a standard mercury reference sphygmomanometer (ERKA 3000; two observers) and Omron RS6 with PSON or PSOFF. RESULTS: A total of 85 participants (39 men, 46 women) were included in this study, with a mean age of 53.5±16.4 years. SBP at entry was 133.0±19.9 mmHg and DBP was 81.3±11.8 mmHg. The two observers for SBP and DBP measurements were in good agreement, with agreements of -0.2±1.5 mmHg for SBP and -0.2±1.5 mmHg for DBP, respectively. The mean difference between PSON readings and readings from the standard device was -2.6±6.1 mmHg for SBP and -1.4±4.8 mmHg for DBP. The differences in PSOFF readings were -4.5±6.9 and -3.2±5.4 mm Hg, respectively (P<0.01; PSON vs. PSOFF). A higher proportion of patients had a small deviation (≤5 mmHg) from the reference device when the positioning sensor was on (65 vs. 54% for SBP and 76 vs. 65% for DBP readings). Using the positioning sensor, the variation in wrist height compared with PSOFF decreased. CONCLUSION: The Omron RS6 position sensor is an important function for a wrist device that improves measurement accuracy by decreasing variations in wrist height.