Age effects on the differences between Omron HEM 907 blood pressure monitor and manual mercury sphygmomanometer blood pressure readings

Chong Guk Lee; Ji Won Park; Jin Soo Moon; Nam Su Kim; Ki Hyeok Kim

doi:10.5646/jksh.2011.17.3.114

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Lee, Park, Moon, Kim, and Kim: Age effects on the differences between Omron HEM 907 blood pressure monitor and manual mercury sphygmomanometer blood pressure readings

Original Article

J Korean Soc Hypertens 2011;17(3):114-124.

Published online: 10 September 2011

DOI: https://doi.org/10.5646/jksh.2011.17.3.114

Age effects on the differences between Omron HEM 907 blood pressure monitor and manual mercury sphygmomanometer blood pressure readings

Chong Guk Lee, MD^1,, Ji Won Park, MD¹, Jin Soo Moon, MD¹, Nam Su Kim, MD², Ki Hyeok Kim, MD³

¹Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea

²Department of Pediatrics, Hanyang Univerdity Hospital, Hanyang University College of Medicine, Seoul, Korea

³Department of Pediatrics, Ilsan Hospital, National Health Insurance Center, Goyang, Korea

Tel: 031) 910-7109, Fax: 031) 910-7108 E-mail: chonglee@paik.ac.kr

Received 18 August 201123 September 2011 Accepted 23 September 2011

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background:

To validate Omron HEM 907 XL blood pressure monitor (test device) against auscultatory mercury sphygmomanometer in children aged 7–18 years old in accordance with International Protocol of European Society of Hypertension revised in 2010 (ESH-IP2) and British Hypertension Society (BHS) protocol.

Methods:

Seventy-five children and adolescents were recruited for the study. A validation procedure was performed following the protocol which was prepared on the basis of ESH-IP2 and BHS protocol for children and adolescents. Each underwent 7 sequential blood pressure (BP) measurements alternatively with a mercury sphygmomanometer and the test device. The results were analyzed according to the validation criteria of ESH-IP2.

Results:

The mean BP (± standard deviation [SD]) difference of absolute value between the test device and mercury sphygmomanometer readings in all the 75 subjects was 3.26 ±3.08 mm Hg for systolic BP and 4.11 ±3.50 mm Hg for diastolic BP. These results fulfilled AAMI criterion of mean ±SD below 5 ±8 mm Hg for both systolic and diastolic BP. The proportion of test device-observer mercury sphygmomanometer BP differences within 5, 10 and 15 mm Hg were 81%, 96%, 99% for SBP and 72%, 93%, 99% for diastolic blood pressure (DBP), respectively, in the part 1 analysis, so both systolic blood pressure (SBP) and DBP passed the part 1 criteria. As for the part 2 analysis, SBP passed the criteria, bur DBP failed.

Conclusions:

Omron HEM 907 XL BP monitor failed an adapted ESH-IP2, though SBP passed. When comparing the BP readings by oscillometers with mercury sphygmomanometer, the differences between them, particularly in diastolic BP, should be taken into account, because DBP can be underestimated.

Keywords: Blood pressure determination, Children, Oscillometry, Validation study

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Fig. 1.

Plot of pressure differences between the test device and the better observer (y-axis), and mean pressure of the observer and the device (x-axis), for systolic blood pressure in children and adolescents. BP, blood pressure.

Fig. 2.

Plot of pressure differences between the test device and the better observer (y-axis), and mean pressure of the observer and the device (x-axis), for diastolic blood pressure in children and adolescents. BP, blood pressure.

Table 1.

Distribution of subjects by age and sex

Age (yr, month)	Male	Female	Number
7,0 – 10,11	13	12	25
11,0 – 14,11	15	11	26
15,0 – 18,11	17	8	25
Total	45	31	76

Table 2.

Means and SDs of BP by sex, age and 50 percentile of height among Korean children and adolescents

	Male			Female
Systolic BP (mm Hg)	Mean (SD)	-1SD	+1SD	Mean (SD)	-1SD	+1SD
8 yr	97.6 (10.2)	87.4	107.8	102.2 (11.0)	91.2	113.2
12 yr	108.1 (11.2)	96.9	119.3	106.0 (10.9)	95.1	116.9
16 yr	115.1 (14.4)	100.7	129.5	105.5 (11.3)	94.2	116.8
Diastolic BP (mm Hg)
8 yr	56.0 (8.6)	47.4	64.6	58.0 (8.0)	50.0	66.0
12 yr	59.7 (7.6)	52.1	67.3	59.3 (7.9)	51.4	67.2
16 yr	59.7 (8.7)	51	68.4	60.7 (7.6)	53.1	68.3

BP, blood pressure; SD, standard deviation.

Table 3.

Subjects details

Sex
Male : Female	44 : 31
Age (yr)
Range (low : high)	7 yr 1 month : 8 yr 11 month
Mean (± SD)	13 yr (3 yr 6 month)
Right upper arm (cm)
Range (low : high)	20.0 : 39.6
Mean (± SD)	24.9 (3.6)
Cuff (Omron HEM 907 XL)
Children (17 – 22 cm)	17
Small adult (22 – 32 cm)	54
Large adult (32 – 42 cm)	4
BP (mm Hg)	SBP	DBP
Range (low : high)	88 : 147	48 : 80
Mean (± SD)	106.8 (11.3)	61.9 (8.5)

BP, blood pressure; SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 4.

Distribution of subjects by the range of blood pressure (BP) (7 – 18 years of age)

	Male	Femal	e Total
Systolic BP (mm Hg)
Low < ‑ 1SD	2	6	8
Mean	33	25	58
High > + 1SD	8	1	9
Diastolic BP (mm Hg)
Low < ‑ 1SD	1	6	7
Mean	29	20	49
High > + 1SD	13	6	19

SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

Table 5.

Observer measurements in each recruitment range

SBP (mm Hg)		DBP (mm Hg)
Range	82 : 147	Range	43 : 81
Low (< 90)	9	Low (< 50)	9
Medium (90 – 130)	207	Medium (50 – 80)	215
High (> 130)	9	High (> 80)	1
Maximum difference	198	Maximum difference	214

SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 6.

Observer differences

	SBP (mm Hg)	DBP (mm Hg)	Repeat
Observer 1 -
Observer 2
Range (low : high)	0 : 3	0 : 4
Mean (± SD)	0.8 (0.9)	0.9 (1.0)	12

SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

Table 7.

Results of the validation analysis of blood pressure readings (n = 225)

Part 1	≤5 mm Hg	≤10 mm Hg	≤15 mm Hg	Grade 1	Mean (mm Hg)	SD (mm Hg)
Pass requirement
Two of	165 (73)	198 (88)	219 (97)
All of	147 (65)	185 (82)	212 (94)
Achieved
SBP	183 (81)	216 (96)	224 (99)	Pass	3.26	3.08
DBP	162 (72)	210 (93)	223 (99)	Pass	4.11	3.50

Values are presented as number (%).

SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

Table 8.

Results of the validation analysis of individual children (n = 75)

Part 2	2/3	0/3	Grade 2	Grade 3
Part 2	≤5 mm Hg	≤5 mm Hg	Grade 2	Grade 3
Pass requirement	≥55 (73)	≤7 (9)
Achieved
SBP	66 (88)	3 (4)	Pass	Pass
DBP	59 (78)	9 (12)	Fail	Fail

Values are presented as number (%).

SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

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