Statistical considerations for testing automated sphygmomanometers in special patient populations.

The International Standards Organization 81060-2:2018 is the current global Standard for the validation of automated sphygmomanometers. It specifies the requirements for clinical studies on the general population, as well as additional requirements for special populations, which might have physiologic characteristics that affect the accuracy of blood pressure measurements. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in these special populations and specifically addresses the pregnant patient population.

A new noninvasive finger sensor (NICCI system) for continuous blood pressure and pulse pressure variation monitoring: A method comparison study in patients having neurosurgery.

BACKGROUND: The NICCI system (Getinge, Gothenburg, Sweden) is a new noninvasive haemodynamic monitoring system using a finger sensor. OBJECTIVES: We aimed to investigate the performance of the NICCI system to measure blood pressure and pulse pressure variation compared with intra-arterial measurements. DESIGN: A prospective method comparison study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PATIENTS: Forty-seven neurosurgery patients. MAIN OUTCOME MEASURES: We performed a method comparison study in 47 neurosurgery patients to compare NICCI blood pressure measurements (BP NICCI ) with intra-arterial blood pressure measurements (BP ART ) (Bland-Altman analysis, four-quadrant plot, error grid analysis) and NICCI pulse pressure variation measurements (PPV NICCI ) with pulse pressure variation calculated manually from the intra-arterial blood pressure waveform (PPV ART ) (Bland-Altman analysis, predictive agreement, Cohen's kappa). RESULTS: The mean of the differences ±â€Šstandard deviation (95% limits of agreement) between BP NICCI and BP ART was 11 ±â€Š10 mmHg (-8 to 30 mmHg) for mean blood pressure (MBP), 3 ±â€Š12 mmHg (-21 to 26 mmHg) for systolic blood pressure (SBP) and 12 ±â€Š10 mmHg (-8 to 31 mmHg) for diastolic blood pressure (DBP). In error grid analysis, 54% of BP NICCI and BP ART MBP measurement pairs were classified as 'no risk', 43% as 'low risk', 3% as 'moderate risk' and 0% as 'significant risk' or 'dangerous risk'. The mean of the differences between PPV NICCI and PPV ART was 1 ±â€Š3% (-4 to 6%). The predictive agreement between PPV NICCI and PPV ART was 80% and Cohen's kappa was 0.55. CONCLUSIONS: The absolute agreement between BP NICCI and BP ART was not clinically acceptable. We recommend not using the current version of the NICCI system for blood pressure monitoring during surgery. The absolute agreement between PPV NICCI and PPV ART was clinically acceptable with moderate predictive agreement regarding pulse pressure variation categories. The NICCI system needs to be further developed and re-evaluated when an improved version is available. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (DRKS00023188) on 2 October 2020.

Right ventricular and pulmonary artery pulse pressure variation and systolic pressure variation for the prediction of fluid responsiveness: an interventional study in coronary artery bypass surgery patients.

PURPOSE: Predicting fluid responsiveness is essential when treating surgical or critically ill patients. When using a pulmonary artery catheter, pulse pressure variation and systolic pressure variation can be calculated from right ventricular and pulmonary artery pressure waveforms. METHODS: We conducted a prospective interventional study investigating the ability of right ventricular pulse pressure variation (PPVRV) and systolic pressure variation (SPVRV) as well as pulmonary artery pulse pressure variation (PPVPA) and systolic pressure variation (SPVPA) to predict fluid responsiveness in coronary artery bypass (CABG) surgery patients. Additionally, radial artery pulse pressure variation (PPVART) and systolic pressure variation (SPVART) were calculated. The area under the receiver operating characteristics (AUROC) curve with 95%-confidence interval (95%-CI) was used to assess the capability to predict fluid responsiveness (defined as an increase in cardiac index of > 15%) after a 500 mL crystalloid fluid challenge. RESULTS: Thirty-three patients were included in the final analysis. Thirteen patients (39%) were fluid-responders with a mean increase in cardiac index of 25.3%. The AUROC was 0.60 (95%-CI 0.38 to 0.81) for PPVRV, 0.63 (95%-CI 0.43 to 0.83) for SPVRV, 0.58 (95%-CI 0.38 to 0.78) for PPVPA, and 0.71 (95%-CI 0.52 to 0.89) for SPVPA. The AUROC for PPVART was 0.71 (95%-CI 0.53 to 0.89) and for SPVART 0.78 (95%-CI 0.62 to 0.94). The correlation between pulse pressure variation and systolic pressure variation measurements derived from the different waveforms was weak. CONCLUSIONS: Right ventricular and pulmonary artery pulse pressure variation and systolic pressure variation seem to be weak predictors of fluid responsiveness in CABG surgery patients.

Agreement between continuous noninvasive finger cuff-derived and invasive arterial blood pressure measurements: Effect of data sampling and data processing.

BACKGROUND: The effect of different methods for data sampling and data processing on the results of comparative statistical analyses in method comparison studies of continuous arterial blood pressure (AP) monitoring systems remains unknown. OBJECTIVE: We sought to investigate the effect of different methods for data sampling and data processing on the results of statistical analyses in method comparison studies of continuous AP monitoring systems. DESIGN: Prospective observational study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany, from April to October 2019. PATIENTS: 49 patients scheduled for neurosurgery with AP measurement using a radial artery catheter. MAIN OUTCOME MEASURES: We assessed the agreement between continuous noninvasive finger cuff-derived (CNAP Monitor 500; CNSystems Medizintechnik, Graz, Austria) and invasive AP measurements in a prospective method comparison study in patients having neurosurgery using all beat-to-beat AP measurements (Methodall), 10-s averages (Methodavg), one 30-min period of 10-s averages (Method30), Method30 with additional offset subtraction (Method30off), and 10 30-s periods without (Methodiso) or with (Methodiso-zero) application of the zero zone. The agreement was analysed using Bland-Altman and error grid analysis. RESULTS: For mean AP, the mean of the differences (95% limits of agreement) was 9.0 (-12.9 to 30.9) mmHg for Methodall, 9.2 (-12.5 to 30.9) mmHg for Methodavg, 6.5 (-9.3 to 22.2) mmHg for Method30, 0.5 (-9.5 to 10.5) mmHg for Method30off, 4.9 (-6.0 to 15.7) mmHg for Methodiso, and 3.4 (-5.9 to 12.7) mmHg for Methodiso-zero. Similar trends were found for systolic and diastolic AP. Results of error grid analysis were also influenced by using different methods for data sampling and data processing. CONCLUSION: Data sampling and data processing substantially impact the results of comparative statistics in method comparison studies of continuous AP monitoring systems. Depending on the method used for data sampling and data processing, the performance of an AP test method may be considered clinically acceptable or unacceptable.

A novel art of continuous noninvasive blood pressure measurement.

Wearable sensors to continuously measure blood pressure and derived cardiovascular variables have the potential to revolutionize patient monitoring. Current wearable methods analyzing time components (e.g., pulse transit time) still lack clinical accuracy, whereas existing technologies for direct blood pressure measurement are too bulky. Here we present an innovative art of continuous noninvasive hemodynamic monitoring (CNAP2GO). It directly measures blood pressure by using a volume control technique and could be used for small wearable sensors integrated in a finger-ring. As a software prototype, CNAP2GO showed excellent blood pressure measurement performance in comparison with invasive reference measurements in 46 patients having surgery. The resulting pulsatile blood pressure signal carries information to derive cardiac output and other hemodynamic variables. We show that CNAP2GO can self-calibrate and be miniaturized for wearable approaches. CNAP2GO potentially constitutes the breakthrough for wearable sensors for blood pressure and flow monitoring in both ambulatory and in-hospital clinical settings.

Changes in haemodynamic and autonomous nervous system parameters measured non-invasively throughout normal pregnancy.

OBJECTIVE: To examine non-invasively haemodynamic and autonomous parameters throughout normal pregnancy. STUDY DESIGN: We used the Task Force Monitor 3040i system to retrieve, record, and calculate haemodynamic as well as autonomous parameters. 20 healthy women were included and scheduled for longitudinal examinations throughout normal pregnancy. Heart rate (HR), blood pressure (BP), stroke volume (SV), cardiac output (CO), systemic vascular resistance (SVR), heart rate variability (HRV), blood pressure variability (BPV), and baroreceptor sensitivity (BRS) were measured. Measurements were performed at gestational week 10(+0)-13(+6), 15(+0)-18(+6), 20(+0)-22(+6), and >30(+0). RESULTS: HR increased during gestation showing a significant increase at III versus I trimester (74 bpm vs. 88 bpm, P<.05). Mean arterial pressure remained stable until III trimester, when a significant increase compared to I trimester could be noted (78 mm Hg vs. 86 mm Hg, P<.05). SV and CO remained relatively stable in I and II trimester, and in III trimester significant decreases were observed. In contrast, SVR increased significantly at III trimester (P<.001). Whereas HRV and BPV did not change at different gestational ages, BRS was significantly lower in III trimester compared to I trimester values (P<.05). CONCLUSION: The non-invasive determination of cardiovascular and autonomous parameters throughout pregnancy is possible and the results of this pilot study can serve as basic parameters for classifying and assessing cardiovascular and autonomous changes in pathological conditions in pregnancy such as hypertensive disorders.