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

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 arteria...

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Published inAnesthesia and analgesia Vol. 128; no. 3; pp. 477 - 483
Main Authors Rogge, Dorothea E., Nicklas, Julia Y., Schön, Gerhard, Grothe, Oliver, Haas, Sebastian A., Reuter, Daniel A., Saugel, Bernd
Format Journal Article
LanguageEnglish
Published United States International Anesthesia Research Society 01.03.2019
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Abstract 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/m), 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.
AbstractList 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/m), 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.
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.BACKGROUNDContinuous 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.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).METHODSIn 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).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.RESULTSWe 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.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.CONCLUSIONSDuring 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.
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. 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). 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. 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.
Author Haas, Sebastian A.
Saugel, Bernd
Nicklas, Julia Y.
Reuter, Daniel A.
Rogge, Dorothea E.
Schön, Gerhard
Grothe, Oliver
AuthorAffiliation Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Institute of Operations Research, Karlsruhe Institute of Technology, Karlsruhe, Germany
From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine
AuthorAffiliation_xml – name: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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Snippet BACKGROUND:Continuous monitoring of arterial pressure is important in severely obese patients who are at particular risk for cardiovascular complications....
Continuous monitoring of arterial pressure is important in severely obese patients who are at particular risk for cardiovascular complications. Innovative...
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SubjectTerms Adult
Arterial Pressure - physiology
Bariatric Surgery - methods
Bariatric Surgery - standards
Blood Pressure Determination - methods
Blood Pressure Determination - standards
Female
Humans
Male
Middle Aged
Monitoring, Intraoperative - methods
Monitoring, Intraoperative - standards
Obesity - physiopathology
Obesity - surgery
Prospective Studies
Title Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system)
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https://www.ncbi.nlm.nih.gov/pubmed/30649073
https://www.proquest.com/docview/2179381775
Volume 128
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