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PubMed1988

A validation study of the Del Mar Avionics Pressurometer IV according to AAMI guidelines.

Guidelines for the evaluation of automatic non-invasive blood pressure (BP) measurement devices have recently been established by the Association for the Advancement of Medical Instrumentation (AAMI). We evaluated the Del Mar Avionics Pressurometer IV (P4) in tests on 109 subjects, according to these guidelines. Three readings by two observers using a double stethoscope were first compared to each other to determine a standard and then averaged and compared to readings obtained using the P4. The two observers agreed within +/- 6 mmHg or 90% of the readings for both systolic and diastolic BP, with correlations of 0.99 and 0.98 for systolic and diastolic BP, respectively. The observers and the P4 in turn agreed to within +/- 6 mmHg for 85% of the readings for systolic BP, with a correlation of 0.98, and 65% of the readings for diastolic BP, with a correlation of 0.69. The correlations for both systolic and diastolic BP increased to 0.99 when readings were restricted to those obtained in individuals who fulfilled our previously defined calibration criterion of +/- 5 mmHg. In addition, we evaluated nine measurements of performance over 60 ambulatory recordings. The most serious problem was that of missing data which occurred in 85% of the recordings, primarily during sleep hours, and was generally attributed to either detection of Korotkoff sounds below 40 mmHg or a failure to detect Korotkoff sounds.

Adult↗
PubMed1989

Clinical evaluation of the Colin ABPM 630 at rest and during exercise: an ambulatory blood pressure monitor with gas-powered cuff inflation.

The Colin ABPM 630 is a silent, gas-powered (CO2) ambulatory blood pressure monitor which uses both ausculatory and/or oscillometric methods to measure blood pressure. We compared simultaneous, same-arm blood pressures obtained with the monitor with those made by two blinded, skilled clinicians using a mercury column and teaching stethoscope. In a second study, the monitor readings were also compared with opposite-arm intra-arterial recordings of blood pressure. The group mean systolic blood pressures obtained by the Colin monitor via the Korotkoff mode were almost identical to the mercury column readings (127.8 +/- 19.4 versus 128.1 +/- 19.3 mmHg, P = NS) and the limit of agreement (2 standard deviations) for the differences in the two methods was +/- 9 mmHg. The diastolic blood pressure obtained by the Colin monitor was significantly lower than the clinician's readings (-6.0 +/- 5.9 mmHg, P less than 0.0001). Similar findings were obtained with the oscillometric mode, however, the mean systolic blood pressure given by the monitor was slightly higher than that given by the mercury column (1.9 +/- 4.5 mmHg, P less than 0.001). In contrast to the mercury column comparisons, the mean diastolic blood pressure obtained with the monitor was nearly the same as the mean intra-arterial diastolic blood pressure for both the Korotkoff (0.1 +/- 5.6 mmHg) and the oscillometric modes (1.2 +/- 6.3 mmHg). During 100-watt bicycle exercise, there was a considerably greater scatter in the individual comparisons of the monitor and intra-arterial blood pressure than that seen in the measurements at rest, but the group means were again similar.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

Clinical evaluation of the Accutracker II ambulatory blood pressure monitor: assessment of performance in two countries and comparison with sphygmomanometry and intra-arterial blood pressure at rest and during exercise.

In order to assess the Accutracker II (Suntech Medical Instruments, Raleigh, North Carolina, USA), a relatively new ambulatory blood pressure (BP) monitor, versus standard forms of BP measurement, we compared same- and contralateral-arm measurements made, via a t-tube connected to a mercury column sphygmomanometer, by two clinicians using a teaching stethoscope and by intra-arterial recordings. Average systolic BP values obtained using the Accutracker II were similar to both the mercury column and intra-arterial determinations, but average diastolic BP values were lower than both the average mercury column (2.8 +/- 4.2 mmHg, P less than 0.001) and intra-arterial measurements (2.0 +/- 4.7 mmHg, P less than 0.02). During isometric exercise and 100-watt bicycle exercise, there were greater limits of agreement for the differences in BP between the Accutracker II and the intra-arterial transducer than were observed for the resting measurements, but these differences were no greater than those observed between intra-arterial and clinician-determined BP measurements. The clinical performance of the Accutracker II was assessed using 119 hypertensive subjects (84 in Norway and 35 in the USA) who wore the monitor for 24 h. While there was good-to-excellent data return in both countries, there were significantly less error codes secondary to excessive arm motion observed in Norway. Our data demonstrate that the Accutracker II is quite accurate compared with both the mercury column and intra-arterial methods of measuring BP, and performs well during 24 h outpatient activities. Our findings also indicate certain geographical differences which may be important in the performance of ambulatory BP-monitoring studies.

Adolescent↗
PubMed2002

Accuracy and reliability of wrist-cuff devices for self-measurement of blood pressure.

OBJECT: Self-measurement of blood pressure (BP) might offer some advantages in diagnosis and therapeutic evaluation and in patient management of hypertension. Recently, wrist-cuff devices for self-measurement of BP have gained more than one-third of the world market share. In the present study, we validated wrist-cuff devices and compared the results between wrist- and arm-cuff devices. The factors affecting the accuracy of wrist-cuff devices were also studied. METHOD: The research group to assess the validity of automated blood pressure measuring device consisted of 13 institutes in Japan, which validated two wrist-cuff devices (WC-1 and WC-2) and two arm-cuff devices (AC-1 and AC-2). They used a crossover method, where the comparison was done between auscultation, by two observers by means of a double stethoscope on one arm and the device on the opposite arm or wrist. RESULTS: There was good inter-observer agreement for the auscultation method in each institute (systolic blood pressure (SBP), -0.1 +/- 2.8 mmHg; diastolic blood pressure (DBP), -0.1 +/- 2.6 mmHg, n = 498). The mean difference between auscultation and the device was minimal both in arm-cuff devices (mean difference for AC-1, 2.2/1.9 mmHg, n = 97 and for AC-2, 5.1/2.9 mmHg, n = 136, SBP/DBP) and wrist-cuff devices (mean difference for WC-1, -2.1/1.2 mmHg, n = 173 mmHg and for WC-2, -2.3/-5.6 mmHg, n = 92). The standard deviation of the difference (SDD) in wrist-cuff devices, however (SDD for WC-1, 9.7/7.3 mmHg and for WC-2, 10.2/8.6 mmHg), was larger than that of the arm-cuff devices (SDD for AC-1, 5.6/6.6 mmHg and for AC-2, 6.3/5.1 mmHg). Grading of AC-1 and AC-2 based on criteria of British Hypertension Society was A/A and B/A, respectively, while that of WC-1 and WC-2 was C/B and D/B, respectively. Using the same validation protocol, the results of validation for one device were divergent in each institute. In wrist-cuff devices, the BP value obtained in palmar flexion was significantly higher and that obtained in palmar dorsiflexion was significantly lower than that in palmar extension. In some cases, finger plethysmogram did not disappear during maximum inflation of the wrist-cuff (congruent with 250 mmHg), even in palmar extension and especially in palmar flexion, suggesting incomplete obstruction of radial and/or ulnar arteries during inflation. CONCLUSION: The results suggest that wrist-cuff devices in the present form are inadequate for self-measurement of blood pressure and, thus, are inadequate for general use or clinical and practical use. However, there is much possibility in wrist-cuff device and the accuracy and reliability of wrist-cuff device are warranted by an improvement of technology.

Adolescent↗
PubMed1980

Human speech and blood pressure.

The recent development of a noninvasive automated blood pressure device has revealed a strong relationship between human conversation and blood pressure. Conventional techniques of pressure measurement such as the stethoscope and manometer, which require silence during the measurement, tended to obscure this important relationship. Findings from this study indicate that interpersonal communications surrounding the measurement of blood pressure can rapidly alter systolic and diastolic pressures. In certain situations, changes greater than 20 per cent in systolic and diastolic blood pressure and heart rate can occur within 30 seconds after the initiation of human speech. Such variance can be of critical significance in making clinical judgments concerning hypertension. These findings are discussed in the context of recent nonpharmacological treatment approaches being developed to help control hypertension.

Adult↗
PubMed1994

The reliability of detecting screw penetration of the acetabulum by intraoperative auscultation.

Open reduction and internal fixation of the acetabulum frequently requires placement of screws in a blind fashion that risks penetrating the joint surface. While in the operative suite, direct visualization of the joint surface may not be possible, and fluoroscopy can be difficult to interpret. Auscultation of the hip with motion in a quiet room has been suggested as a useful adjunct to detecting screw penetration. Carrying that concept further, we auscultate the hip using a sterile esophageal stethoscope at the operating table and have found this to be a highly reliable method of detecting intraarticular screw placement. To test the reliability and reproducibility of this technique, an experiment was performed using inexperienced volunteers. In part I, two adult mongrel dogs were prepared. A screw was placed violating the hip joint in one dog, and in the other dog a screw was placed near but not penetrating the joint. Screw placement was verified under direct vision. Seventy-seven volunteers who did not know which hip was penetrated then auscultated both hips in random order and recorded their impressions after each hip was heard. After hearing both hips, 74 of 77 were able to identify the screw in the hip joint correctly; 69 were able to recognize the extraarticular screw correctly. In part II, both hips of a human cadaver were exposed and dislocated. In one hip, a screw was placed that tangentially violated the joint, and in the same area of the contralateral hip a screw was placed that did not penetrate the joint surface.(ABSTRACT TRUNCATED AT 250 WORDS)

Acetabulum↗
PubMed2001

Reducing the cost of frequent hospital admissions for congestive heart failure: a randomized trial of a home telecare intervention.

BACKGROUND: The high cost of caring for patients with congestive heart failure (CHF) results primarily from frequent hospital readmissions for exacerbations. Home nurse visits after discharge can reduce readmissions, but the intervention costs are high. OBJECTIVES: To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges: 1) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope; 2) nurse telephone calls; and 3) usual outpatient care. RESEARCH DESIGN: One-year randomized trial. SUBJECTS: English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF. MEASURES: Our primary outcome was CHF-related readmission charges during a 6-month period after randomization. Secondary outcomes included all-cause readmissions, emergency department (ED) visits, and associated charges. RESULTS: Thirty-seven subjects were randomized: 13 to home telecare, 12 each telephone care and 12 to usual care. Mean CHF-related readmission charges were 86% lower in the telecare group ($5850, SD $21,094) and 84% lower in the telephone group ($7320, SD $24,440) than in the usual care group ($44,479, SD $121,214). However, the between-group difference was not statistically significant. Both intervention groups had significantly fewer CHF-related ED visits (P = 0.0342) and charges (P = 0.0487) than the usual care group. Trends favoring both interventions were noted for all other utilization outcomes. CONCLUSIONS: Substantial reductions in hospital readmissions, emergency visits, and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring. Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive.

Adult↗
PubMed1996

Ambient noise interferes with auscultatory blood pressure measurement during exercise.

This study was designed to investigate whether the acoustical characteristics of the Korotkoff sounds (K-sounds) were altered during exercise and/or masked by the ambient noise. After signing informed consent, 11 subjects (8 females, 3 males; 27 +/- 2 yr; 166.2 +/- 3.2 cm; 62 +/- 5 kg; means +/- SD) underwent a cycle ergometer exercise test that increased in workload by 30 W every 3 min until volitional fatigue. Heart rate, auscultatory systolic (SBP) and diastolic blood pressure (DBP), and oxygen consumption were monitored 1 and 2 min into each work stage. The auscultatory K-sounds were recorded with a microphone mounted in a stethoscope tube for later frequency (Hz) and sound pressure level (dB SPL) analysis. Frequency and SPL of ambient noise (99 +/- 13 Hz and 64 +/- 1 db at maximum, respectively) increased during the exercise test to magnitudes similar to the SBP and DBP K-sounds (166 Hz, 66 db; and 128 Hz, 69 db, respectively). Additionally, the ambient noise was responsible for a significant damping of the frequency and SPL of the measured blood pressure K-sounds and a rise in the measured frequency of the SBP K-sounds. Furthermore, we observed "inaudible" K-sounds at lower frequencies than adjoining audible K-sounds (100 Hz vs 126 Hz), supporting the known underestimation of SBP by auscultation. The increase in ambient noise during exercise testing dampens and may mask the auscultatory K-sounds, thus making detection of the proper K-sounds during exercise difficult at best. Furthermore, the presence of inaudible K-sounds may further explain the published discrepancies between auscultatory and intraarterial blood pressure measurements during exercise.

Acoustics↗
PubMed1984

Effects of statistical quality, sampling rate and temporal filtering techniques on the extraction of functional parameters from the left ventricular time-activity curves.

Several techniques for the processing of a series of curves derived from two left ventricular time-activity curves acquired at rest and during exercise with a nuclear stethoscope were evaluated. They were three and five point time smoothing, Fourier filtering preserving one to four harmonics (H), truncated curve Fourier filtering, and third degree polynomial curve fitting. Each filter's ability to recover, with fidelity, systolic and diastolic function parameters was evaluated under increasingly 'noisy' conditions and at several sampling rates. Third degree polynomial curve fittings and truncated Fourier filters exhibited very high sensitivity to noise. Three and five point time smoothing had moderate sensitivity to noise, but were highly affected by sampling rate. Fourier filtering preserving 2H or 3H produced the best compromise with high resilience to noise and independence of sampling rate as far as the recovery of these functional parameters is concerned.

Erythrocytes↗
PubMed1996

Haemodynamic effects of acetazolamide in patients with cardiovascular disorders: correlation with calculated cerebral perfusion reserve.

Individual responses of cerebral blood flow to acetazolamide are highly variable. We hypothesized that this may be due to interactions with cardiovascular diseases and medication. Therefore, we measured the haemodynamic effects of acetazolamide in patients with various cardiovascular disorders and evaluated whether these had any correlation with calculated cerebral perfusion reserve. Ten male patients aged 58 +/- 9 years (mean +/- S.D.) were studied with first-pass radionuclide ventriculography and echocardiography before and 20 min after the administration of 1 g acetazolamide. Systolic blood pressure fell from 133 +/- 21 to 128 +/- 19 mmHg (P < 0.05) and the cardiac output to total blood volume ratio increased from 0.85 +/- 0.18 to 0.92 +/- 0.11 (P = 0.05), indicating a 14% reduction in peripheral vascular resistance. In a further study, 15 patients aged 60 +/- 7 years (22 studies) were studied simultaneously with a nuclear stethoscope and 99Tc(m)-hexamethylpropyleneamine oxime single photon emission tomography before and after acetazolamide administration. The cardiac output ratio increased from 0.81 +/- 0.17 to 0.89 +/- 0.17 (P < 0.05) and showed a significant inverse correlation with calculated cerebral perfusion reserve. In conclusion, acetazolamide increases the cardiac output ratio and reduces systolic blood pressure, indicating reduced peripheral vascular resistance in patients with various cardiovascular diseases and medication. The increase in the cardiac output ratio is inversely related with calculated cerebral perfusion reserve. This helps to explain the high individual variability in calculated cerebral perfusion reserve.

Acetazolamide↗
PubMed2001

Historical controversy in health technology assessment: the case of electronic fetal monitoring.

Electronic fetal monitoring (EFM) was introduced in the late 1950s as an alternative to traditional auscultation by stethoscope or fetoscope in the management of labor and delivery. The new technology was seen as a valuable tool in the prevention of cerebral palsy and other adverse fetal outcomes and diffused rapidly into clinical practice. In the late 1970s, some scepticism began to be voiced about the evidence for the effectiveness of EFM. The authors published a systematic review of the evidence in 1979 that concluded that there was insufficient evidence for the effectiveness of the routine use of EFM and a clear rise in the cesarean delivery rate associated with its use. The analysis was based on a thorough review of approximately 600 books and articles, but focused heavily on the evidence of four randomized clinical trials (RCTs) that had been published. An economic analysis further underscored the importance of this issue. The report was met with harsh ad hominem criticism from clinicians both in public venues and in the medical literature. Subsequently, additional RCTs were conducted and other analyzes were published, and in 1987 the American College of Obstetricians and Gynecologists recommended that auscultation was an acceptable alternative to EFM in routine labor and delivery. Yet, today EFM continues to be the standard of practice, used in 80% of labors in this country. The most important conclusion drawn from this experience is the need to evaluate new technologies before their widespread diffusion into clinical practice.

Attitude of Health Personnel↗
PubMedDate not supplied

Tourniquet safety in lower leg applications.

PURPOSE: To reduce the chance of injury due to pneumatic tourniquet use, the minimum cuff pressure required to maintain a bloodless field should be used. The purpose of this study was to find out if Limb Occlusion Pressure (LOP--the cuff pressure required to occlude arterial flow) is lower with a wide contoured cuff than with a standard width cylindrical cuff at the calf, if cuff pressures based on measured LOP will be lower than the typical 250 mmHg used in lower leg cuffs, and if a new automatic LOP measurement method gives the same results as the standard Doppler stethoscope method. SAMPLE: 16 adult volunteers were tested in a controlled laboratory setting, and 53 clinical cases were reviewed at two centers. DESIGN: Repeated measures comparison of LOP on volunteers with the two different cuffs and measurement methods, and review of clinical cases. RESULTS: LOP was lower with the wide cuff on all volunteers (mean reduction 20 mmHg, SD 8.6, range 5-35, p < 0.001). The average difference of 1.2 mmHg between Doppler and automatic LOP readings was not significant (p = 0.43). Based on the volunteer results, using LOP plus a safety margin of 40, 60, or 80 mmHg (for LOP < 130, 131-190, or 190+ respectively) with a standard width cylindrical cuff will lead to an average cuff pressure of 223 mmHg (range 170-299, SD 36), 11% lower than typical practice and up to 80 mmHg (32%) lower on some patients. Using a wide, contoured cuff should further reduce cuff pressures to an average of 195 mmHg (range 160-280, SD 33), 22% lower than typical practice and a reduction of up to 90 mmHg (36%). At two clinics, the wide cuff maintained a bloodless field in 48 out of 53 cases (91%) when used at 200 mmHg. CONCLUSIONS: Using a wide, contoured cuff at the calf should reduce required cuff pressures compared to a standard cuff. Setting cuff pressure based on LOP should further reduce cuff pressures for most patients compared to typically used pressures. With continued development, the new automatic method may become a viable alternative to the Doppler method and may make LOP measurement more practical in the clinical setting.

Adult↗
PubMed2005

Ultrasonography and three-dimensional methods of the upper gastrointestinal tract.

Improved technology and new clinical methods have expanded the possibilities of using ultrasound in the daily routine of gastroenterology. Gastrointestinal ultrasonography can, in principle, be applied in two different ways in patient management. It can be used as one imaging modality among others, for which the clinicians refer the patient to a radiologist, but it can also be used as a clinical tool, similar to the stethoscope, expanding on the clinical findings and paving the way for efficient work-up of patients. Furthermore, ultrasonography has scientific applications; for example, strain rate imaging and three-dimensional ultrasound are advanced methods that allow highly specified and detailed examination of the tissue or organ of interest.

Endoscopy, Gastrointestinal↗
PubMed2000

Validation of A&D UA-767 device for the self-measurement of blood pressure.

BACKGROUND: The validation of self-measurement devices has been recommended. Automatic monitor A&D UA-767 (A&D Company, Ltd, Tokyo, Japan) is well known and widely used, but not tested according to the Association for Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) recommendations. OBJECTIVE: To perform a clinical validation for use by adults of the A&D UA-767 device according to the criteria of the AAMI and a modified BHS protocol. METHODS: The test concerned 101 subjects (57 men and 44 women) aged 15-85 years with arm circumferences of 22-39 cm, a systolic blood pressure (SBP) range of 89-206 mmHg, and a diastolic blood pressure (DBP) range of 53-122 mmHg. For each subject, three readings of the UA-767 were compared with simultaneous auscultatory measurements by two trained independent observers who used a mercury manometer and dual stethoscope. The results were graded according to the BHS (1990 and 1993) and AAMI recommendations. RESULTS: Observers showed close agreement, with mean differences of 1.1+/-2.4 mmHg for SBP and -0.7+/-2.0 mmHg for DBP. The proportion of values agreeing to within 5, 10 and 15 mmHg were 93, 100, and 100% for SBP and 97, 100, and 100% for DBP for the two observers. The sphygmomanometer measurements were 132+/-24/79+/-14 mmHg (mean+/-SD). The average difference between the mercury sphygmomanometer and A&D UA-767 readings for SBP and DBP were, respectively, -0.4+/-5.4 and -0.4+/-4. 8 mmHg. The proportion of values agreeing to within 5,10, and 15 mmHg were 82, 94, and 98% for SBP and 80, 95, and 98% for DBP for the observers and device (A/A grade for BHS). CONCLUSIONS: For an adult population, the A&D UA-767 device for the self-measurement of blood pressure satisfied the AAMI criteria, achieved a BHS grade of A/A and can therefore be recommended for monitoring blood pressure in home and clinical conditions by patients with mild-to-moderate arterial hypertension.

Adolescent↗
PubMed2000

Clinical evaluation of the efficacy of the Braun PrecisionSensor oscillometric wrist blood pressure monitor for use on adults versus auscultation as defined by ANSI/AAMI SP10-1992.

OBJECTIVE: To evaluate the overall performance of a new oscillometric wrist blood pressure monitor (Braun PrecisionSensor, Braun GmbH, Kronberg, Germany) as defined by the ANSI/AAMI SP10-1992 guidelines, and to analyze the data for the optimized selection of the algorithm that derives the blood pressure values from the oscillometric blood pressure curves. METHODS: The clinical trial was a multi-center, open, within-subject evaluation. Repeated sequential blood pressure measurements were taken on the left wrist using the Braun PrecisionSensor, and on the left upper arm using a T-tube stethoscope and a mercury sphygmomanometer as a standard auscultatory blood pressure measurement device. The reported results are based on a sample of 86 adult male and female subjects (57% female, 43% male). Three sets of measurements with each of both devices were evaluated for each individual. RESULTS: Close agreement was obtained between both observers in compliance with the ANSI/AAMI SP10-1992 guidelines. The mean values of the differences between the Braun PrecisionSensor and the mercury sphygmomanometer were 0.1mmHg for systolic and 1.9mmHg for diastolic blood pressure. The standard deviations were 7.1mmHg for systolic and 7.0mmHg for diastolic blood pressure. The use of an optimized algorithm improved the accuracy of the Braun PrecisionSensor, after which the standard deviations were 6.1mmHg for systolic and 6.3mmHg for diastolic blood pressure. CONCLUSIONS: The Braun PrecisionSensor satisfies the Association for the Advancement of Medical Instrumentation's efficacy and safety criteria for both systolic and diastolic blood pressures with both algorithms analyzed.

Adolescent↗
PubMed2002

Clinical evaluation of a self blood pressure monitor according to the First International Consensus Conference on Self Blood Pressure Measurement.

BACKGROUND: The Calor TensioSense Bras automatic blood pressure monitor has obtained European Union certification, but the clinical validity of this new oscillometric device when handled by lay subjects has yet to be evaluated. DESIGN: The design employed prospective and blinded blood pressure measurements and a validation procedure according to the criteria set out by the First International Consensus Conference on Self Blood Pressure Measurement (1999). METHODS: Thirty-three subjects were recruited, 11 in each of three strata of systolic blood pressure (<130, 130-160 and >160 mmHg). Blood pressure was measured sequentially seven times, alternating observer and lay measurements. Two certified observers used two mercury columns and a double stethoscope; the subjects used the automatic device. All blood pressure readings and recordings were blinded. Adequate cuff sizes were used, and the subjects' position was standardized. Discrepancy analysis between manual and automatic measurements was carried out using VAPA software. RESULTS: Dispersion of the discrepancies between manual and automatic measurements showed no specific trend. Out of the 99 systolic blood pressure measurements, 53, 76 and 89 discrepancies were less than 5, 10 and 15 mmHg, respectively. Of the 99 diastolic blood pressure measurements, 62, 86 and 97 discrepancies were less than 5, 10 and 15 mmHg, respectively. The mean inter-observer discrepancy was 1 mmHg for both systolic and diastolic blood pressure comparisons. CONCLUSION: This evaluation showed that this device complies with the international validation protocol requirements. Thus, the device can, providing adequate instruction is given in the clinic, be recommended for self-measurement by patients at home, as well as for clinical or epidemiological research.

Blood Pressure Determination↗
PubMed2005

Validation of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults.

BACKGROUND: We evaluated the clinical validity of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol. METHODS: The blood pressure (BP) was measured at the same arm by two certified observers using two mercury columns and a double stethoscope, then by the volunteer with the automatic device, these measurements were done seven times sequentially using 33 volunteers. For the randomization of the patient, one ABPM measure was compared to the mean of three manual measures. Then, we had three ABPM measures and four manual measures. Each ABPM measure, being compared to two manual measures. Blood pressure readings and recordings were blinded. Position of the subjects was standardized. RESULTS: Phase 1: To pass phase 1, the device had to have at least 25 of the 45 measurements within 5 mmHg, 35 within 10 mmHg or 40 within 15 mmHg of the comparative observer measurements. The AGILIS monitor had 35 measurements lying within 5 mmHg, 42 within 10 mmHg and 45 within 15 mmHg for systolic BP (SBP), 35 within 5 mmHg, 44 within 10 mmHg and 45 within 15 mmHg for diastolic BP (DBP). It passed the criteria for SBP and DBP. Phase 2: To pass phase 2.1, a device must have at least 60 of 99 measurements within 5 mmHg, 75 within 10 mmHg and 90 within 15 mmHg of the comparative observer measurements, and in addition must also have either 65 within 5 mmHg and 80 within 10 mmHg, or 65 within 5 mmHg and 95 within 15 mmHg, or 80 within 10 mmHg and 95 within 15 mmHg. The AGILIS monitor had 78 measurements within 5 mmHg, 91 within 10 mmHg and 96 within 15 mmHg for SBP; and 70 measurements within 5 mmHg, 92 within 10 mmHg and 96 within 15 mmHg for DBP. It passed the criteria for SBP and DBP. For phase 2.2 using the AGILIS monitor, 27 subjects had at least two of the differences within 5 mmHg and none had any differences within 5 mmHg for SBP; 27 subjects had at least two of the differences within 5 mmHg and three subjects had no differences within 5 mmHg for DBP. The results are in concordance with the requested criteria for phase 2.2. CONCLUSION: Thus the AGILIS device fulfils the validation criteria of the international protocol.

Adult↗
PubMed2005

Validation of the TM-2564G device for in-hospital blood pressure measurement.

OBJECTIVE: To perform clinical validation of the TM-2564G device for in-hospital blood pressure measurement according to the British Hypertension Society protocol. METHODS: The tests were carried out on 85 patients aged 19-82 years (41 male patients, mean age 50+/-19 years) with systolic blood pressure 75-219 mmHg and diastolic blood pressure 43-117 mmHg (mean 142+/-33/85+/-20 mmHg). For each patient, three readings of the TM-2564G device were compared with simultaneous auscultatory measurements by two trained independent observers. The observers used a mercury-calibrated sphygmomanometer and dual stethoscope. The results were graded according to the British Hypertension Society protocol 1993. RESULTS: The average difference was -1.85 mmHg for systolic blood pressure and -1.20 mmHg for diastolic blood pressure. The standard deviation of the difference between TM-2564G and the observers' results was 4.85 and 4.16 mmHg for systolic and diastolic blood pressures, respectively. Systolic blood pressure percentage of readings agreeing to within 5 mmHg was 75.7%, 10 mmHg 95.36% and 15 mmHg 99.6%, and for DBP 82.7, 97.6 and 99.8%, respectively. CONCLUSIONS: The TM-2564G device achieved A/A British Hypertension Society grade and can be recommended for in-hospital measurement of blood pressure.

Adult↗