Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system)

TY - JOUR

T1 - Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system)

AU - Rogge, Dorothea E

AU - Nicklas, Julia Y

AU - Schön, Gerhard

AU - Grothe, Oliver

AU - Haas, Sebastian A

AU - Reuter, Daniel A

AU - Saugel, Bernd

PY - 2019/3

Y1 - 2019/3

N2 - BACKGROUND: Continuous monitoring of arterial pressure is important in severely obese patients who are at particular risk for cardiovascular complications. Innovative technologies for continuous noninvasive arterial pressure monitoring are now available. In this study, we compared noninvasive arterial pressure measurements using the vascular unloading technique (Clearsight system; Edwards Lifesciences Corp, Irvine, CA) with invasive arterial pressure measurements (radial arterial catheter) in severely obese patients during laparoscopic bariatric surgery.METHODS: In 35 severely obese patients (median body mass index, 47 kg/m2), we simultaneously recorded noninvasive and invasive arterial pressure measurements over a period of 45 minutes. We compared noninvasive (test method) and invasive (reference method) arterial pressure measurements (sampling rate 1 Hz = 1/s) using Bland-Altman analysis (accounting for multiple measurements per subject), 4-quadrant plot/concordance analysis (2-minute interval, 5 mm Hg exclusion zone), and error grid analysis (calculating the proportions of measurements in risk zones A-E with A indicating no risk, B low risk, C moderate risk, D significant risk, and E dangerous risk for the patient due to the risk of wrong clinical interventions because of measurement errors).RESULTS: We observed a mean of the differences (±SD, 95% limits of agreement) between the noninvasively and invasively assessed arterial pressure values of 1.1 mm Hg (±7.4 mm Hg, -13.5 to 15.6 mm Hg) for mean arterial pressure (MAP), 6.8 mm Hg (±10.3 mm Hg, -14.4 to 27.9 mm Hg) for systolic arterial pressure, and 0.8 mm Hg (±6.9 mm Hg, -12.9 to 14.4 mm Hg) for diastolic arterial pressure. The 4-quadrant plot concordance rate (ie, the proportion of arterial pressure measurement pairs showing concordant changes to all changes) was 93% (CI, 89%-96%) for MAP, 93% (CI, 89%-97%) for systolic arterial pressure, and 88% (CI, 84%-92%) for diastolic arterial pressure. Error grid analysis showed that the proportions of measurements in risk zones A-E were 89.5%, 10.0%, 0.5%, 0%, and 0% for MAP and 93.7%, 6.0%, 0.3%, 0%, and 0% for systolic arterial pressure, respectively.CONCLUSIONS: During laparoscopic bariatric surgery, the accuracy and precision of the vascular unloading technique (Clearsight system) was good for MAP and diastolic arterial pressure, but only moderate for systolic arterial pressure according to Bland-Altman analysis. The system showed good trending capabilities. In the error grid analysis, >99% of vascular unloading technique-derived arterial pressure measurements were categorized in no- or low-risk zones.

AB - BACKGROUND: Continuous monitoring of arterial pressure is important in severely obese patients who are at particular risk for cardiovascular complications. Innovative technologies for continuous noninvasive arterial pressure monitoring are now available. In this study, we compared noninvasive arterial pressure measurements using the vascular unloading technique (Clearsight system; Edwards Lifesciences Corp, Irvine, CA) with invasive arterial pressure measurements (radial arterial catheter) in severely obese patients during laparoscopic bariatric surgery.METHODS: In 35 severely obese patients (median body mass index, 47 kg/m2), we simultaneously recorded noninvasive and invasive arterial pressure measurements over a period of 45 minutes. We compared noninvasive (test method) and invasive (reference method) arterial pressure measurements (sampling rate 1 Hz = 1/s) using Bland-Altman analysis (accounting for multiple measurements per subject), 4-quadrant plot/concordance analysis (2-minute interval, 5 mm Hg exclusion zone), and error grid analysis (calculating the proportions of measurements in risk zones A-E with A indicating no risk, B low risk, C moderate risk, D significant risk, and E dangerous risk for the patient due to the risk of wrong clinical interventions because of measurement errors).RESULTS: We observed a mean of the differences (±SD, 95% limits of agreement) between the noninvasively and invasively assessed arterial pressure values of 1.1 mm Hg (±7.4 mm Hg, -13.5 to 15.6 mm Hg) for mean arterial pressure (MAP), 6.8 mm Hg (±10.3 mm Hg, -14.4 to 27.9 mm Hg) for systolic arterial pressure, and 0.8 mm Hg (±6.9 mm Hg, -12.9 to 14.4 mm Hg) for diastolic arterial pressure. The 4-quadrant plot concordance rate (ie, the proportion of arterial pressure measurement pairs showing concordant changes to all changes) was 93% (CI, 89%-96%) for MAP, 93% (CI, 89%-97%) for systolic arterial pressure, and 88% (CI, 84%-92%) for diastolic arterial pressure. Error grid analysis showed that the proportions of measurements in risk zones A-E were 89.5%, 10.0%, 0.5%, 0%, and 0% for MAP and 93.7%, 6.0%, 0.3%, 0%, and 0% for systolic arterial pressure, respectively.CONCLUSIONS: During laparoscopic bariatric surgery, the accuracy and precision of the vascular unloading technique (Clearsight system) was good for MAP and diastolic arterial pressure, but only moderate for systolic arterial pressure according to Bland-Altman analysis. The system showed good trending capabilities. In the error grid analysis, >99% of vascular unloading technique-derived arterial pressure measurements were categorized in no- or low-risk zones.

KW - Journal Article

U2 - 10.1213/ANE.0000000000003943

DO - 10.1213/ANE.0000000000003943

M3 - SCORING: Journal article

C2 - 30649073

VL - 128

SP - 477

EP - 483

JO - ANESTH ANALG

JF - ANESTH ANALG

SN - 0003-2999

IS - 3

ER -