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original article obstet gynecol sci 2022 65 4 325 334 https doi org 10 5468 ogs 22063 eissn 2287 8580 non invasive continuous blood pressure monitoring using the clearsight system ...

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                 Original Article
                 Obstet Gynecol Sci 2022;65(4):325-334
                 https://doi.org/10.5468/ogs.22063
                 eISSN 2287-8580
               Non-invasive continuous blood pressure monitoring 
               using the ClearSight system for pregnant women at 
               high risks of post-partum hemorrhage: comparison with 
               invasive blood pressure monitoring during cesarean 
               section
                                        1                       2                          2                         1                             1
               Takuya Misugi, PhD , Takashi Juri, PhD , Koichi Suehiro, PhD , Kohei Kitada, PhD , Yasushi Kurihara, PhD , 
                                    1                            1                           1                                1                       2
               Mie Tahara, PhD , Akihiro Hamuro, PhD , Akemi Nakano, PhD , Masayasu Koyama, PhD , Takasi Mori, PhD , 
               Daisuke Tachibana, PhD1
               1                                         2
               Departments of Obstetrics, and Gynecology,  Anesthesiology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan
               Objective
               This study aimed to investigate the accuracy and precision of continuous, non-invasive blood pressure obtained using 
               the ClearSight system by comparing it with invasive arterial blood pressure, and to assess the hemodynamic changes 
               using invasive methods and the ClearSight system in patients undergoing cesarean section.
               Methods
               Arterial pressure was measured invasively with an intra-arterial catheter and non-invasively using the ClearSight 
               system during cesarean section in patients with placenta previa or placenta accreta. Blood pressure measurements 
               obtained using these two means were then compared.
               Results
               Total 1,277 blood pressure measurement pairs were collected from 21 patients. Under Bland-Altman analysis, the 
               ClearSight system demonstrated an acceptable accuracy with a bias and standard deviation of 8.8±13.4 mmHg for 
               systolic blood pressure, -6.3±7.1 mmHg for diastolic blood pressure, and -2.7±8.0 mmHg for median blood pressure. 
               Cardiac index levels were significantly elevated during fetal delivery and 5 minutes after placental removal, and 
               systemic vascular resistance index levels were significantly decreased during fetal delivery and 40 minutes after 
               placental removal. 
               Conclusion
               In patients undergoing cesarean section, the ClearSight system showed excellent accuracy and precision compared to 
               that of the currently used invasive monitoring system.
               Keywords: Blood pressure monitor; Cesarean section; Spinal anesthesia; Postpartum hemorrhage
               Received: 2022.02.17.   Revised: 2022.05.07.   Accepted: 2022.05.31.
               Corresponding author: Takuya Misugi, PhD
               Department of Obstetrics and Gynecology, Faculty of Medicine, Osaka Metropolitan University, 1 Chome-4-3 Asahimachi, Abeno Ward, 
               Osaka 545-8585, Japan 
               E-mail: misutaku1975@infoseek.jp
               https://orcid.org/0000-0001-7775-4570
               Articles published in Obstet Gynecol Sci are open-access, 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.
               Copyright © 2022 Korean Society of Obstetrics and Gynecology 
               www.ogscience.org                                                                                                                       325
                                                                     Vol. 65, No. 4, 2022
              Introduction                                                       Materials and methods
              Post-partum hemorrhage (PPH) is one of the leading causes          1. Study design and patients
              of maternal death in South Korea [1], and it is important to       This prospective observational study was approved by the 
              establish a multidisciplinary treatment beforehand, especially     Institutional Review Board (approval number: 4161; October 
              for pregnant women at a high risk of PPH such as placenta          25, 2018). Written informed consent was obtained from all 
              previa [2,3]. Invasive arterial blood pressure (BP) monitoring,    patients before their inclusion in the study. Patients with pla-
              which provides continuous monitoring as well as access to          centa previa or placenta accreta were enrolled in the study. 
              blood draws, is useful for the management of patients with         Patients with hypertensive disorders during pregnancy, ar-
              PPH during cesarean section and helps maintain adequate            rhythmias, cardiovascular diseases, and multiple pregnancies 
              circulation [4,5]. However, intra-arterial catheterization is in-  were excluded. Patients who underwent cesarean section 
              vasive and carries the potential risk of complications, such as    under general anesthesia were excluded [11]. We also ex-
              nerve injury, infection, and thrombosis [6,7]. The ClearSight      cluded patients who required general anesthesia after spinal 
              system (Edwards Lifesciences, Irvine, CA, USA), a non-inva-        anesthesia (Fig. 1). In all cases, we confirmed the difference 
              sive hemodynamic monitoring device, measures continuous            in systolic blood pressure (SBP) between the right and left 
              non-invasive BP, stroke volume (SV), SV variance, and cardiac      arm and, if it was less than 10 mmHg, it was considered to 
              output (CO) based on the volume clamp method. Several              be within the normal range before performing the cesarean 
              studies on non-pregnant populations have shown excellent           section [12]. 
              accuracy and precision between continuous non-invasive BP 
              monitoring and invasive BP monitoring [8,9]. Furthermore,          2. Anesthetic and obstetrical management
              Juri et al. [10] showed that the ClearSight system could re-       All patients were allowed to consume clear liquid until 3 
              duce and nausea in patients undergoing cesarean section            hours before surgery and were administered a continuous in-
              under spinal anesthesia. However, the accuracy and precision       fusion of Ringer’s lactate solution (200 mL/h) [10]. In the op-
              of the ClearSight system have not yet been validated in preg-      erating room, each patient was positioned on the operating 
              nant women at high risk of PPH.                                    table. Standard hemodynamic monitors, including pulse ox-
               This study aimed 1) to prospectively evaluate the accuracy        imeter and electrocardiography leads were attached. A non-
              and precision of continuous non-invasive BP by comparing           invasive BP cuff (IntelliVue MP70; Philips Electronics, Tokyo, 
              them with invasive BP and 2) to assess the hemodynamic             Japan) was attached to the right arm. Each patient rested 
              changes using the ClearSight system in patients undergoing         for 5 minutes while their baseline BP was measured and an 
              cesarean section.                                                  intra-arterial catheter was inserted into the left forearm.
                                         Pregnant women diagnosed  
                                         placenta previa or accreta (n=41)     Excluded
                                                                               1. Hypertensive disorder (n=0)
                                                                               2. Arrhythmia, cardiovascular disease (n=0)
                                                                               3. Multiple pregnancy (n=1)
                                                                               4. Patients who didn't agree (n=9)
                                                                               Patients underwent a cesarean section under 
                                                                               general anesthesia from the beginning (n=6)
                                                                               Patients necessitated general anesthesia after 
                                                                               spinal anesthesia (n=4)
                                       Final women available for analysis (n=21)
              Fig. 1. Flow diagram of the present study.
              326                                                                                                          www.ogscience.org
                                                    Takuya Misugi, et al. ClearSight system for cesarean section
                To ensure reliable data, the radial artery catheter was            aged to yield one datum. The systemic vascular resistance 
              flushed, the pressure bag was pressurized and maintained at          index (SVRI) was calculated assuming a right atrial pressure 
              300 mmHg, zero-referencing was performed, and the pres-              of 0 mmHg (SVRI=80×MBP/CI) [19]. To ensure simultane-
              sure transducer was zeroed at the level of the right atrium          ous data analysis, the timing of the data registration was 
              and maintained at all times during surgery.                          synchronized across that from ClearSight system monitoring. 
                Cesarean section under spinal anesthesia was performed             During the cesarean section, hemodynamic measurements 
              as described below. Patients were administered 0.5% hyper-           were standardized for each woman. Invasive beat-to-beat 
              baric bupivacaine (11.5 mg) and fentanyl (10  g) in the third        mean arterial pressures were obtained at intervals of >30 
                                                              µ
              lumbar intervertebral space in the right lateral position. After     beat and considered to indicate stable and reliable pressure 
              spinal anesthesia, each patient was immediately returned to          measurements. BP was recorded at 1 minute intervals and 
              the supine position, and the sensory block level at T6 was           stored on an anesthesia monitor (IntelliVue MP70; Philips 
              confirmed. From the beginning of the cesarean section, rapid         Electronics Japan Corp., Tokyo, Japan) [20]. Data considered 
              fluid administration with 6% hydroxyethyl starch 130/0.4/9           to be artifacts were excluded based on the ClearSight sys-
                        ®
              (Voluven ; Fresenius Kabi, Bad Hamburg, Germany) was                 tem auto-calibration function and if they were radial artery 
              started (25 mL/min) until delivery [10]. For patients with an        artifacts or ClearSight system artifacts. Auto-calibration was 
              anterior placenta covering the lower uterine wall, we per-           performed at least once in every 70 heart beats to keep the 
              formed the ward technique to avoid transecting the placenta          finger arteries open and of a constant diameter. In addition, 
              [13,14]. After delivery, the fluid and transfusion management        auto-calibration was performed when the BP measurement 
              were left to the attending anesthesiologist. Oxytocin infusion       was temporarily interrupted for two or more beats. When 
              was started after placental removal at 100 drops per minutes         auto-calibration was performed, SBP, DBP, and MBP had 
              (5 units of oxytocin per 500 mL serum) to achieve effective          the same values, which increased gradually. Therefore, it is 
              uterine contraction, and the on-site hemostatic suturing             possible to discriminate such data as artifacts. Radial artery 
              technique was used to control bleeding from the uterine              artifacts, which result from blood sampling and flushing, can 
              myometrium [15].                                                     be discriminated because SBP and DBP have the same values. 
                                                                                   The ClearSight system artifacts, which occurs owing external 
              3. Measurement of hemodynamic parameters using                       pressure on the ClearSight system cuff, can be recognized as 
              the ClearSight system                                                extreme outliers.
              Hemodynamic measurements with the ClearSight system 
              were obtained using a digital cuff of appropriate size after         4. Comparison of both methods of BP measurements
              anthropometric configuration by height, weight, sex, and             For the comparison of BP measurements obtained from the 
              age. The system continuously measures the BP waveform                intra-arterial catheter and the ClearSight system, bias was 
              in the finger and calculates the beat-to-beat branchial BP           defined as the mean difference between the two meth-
              using an algorithm [16-18]. After calibrating the reference          ods; 95% limits of agreement (LOA) were calculated as 
              transducer to zero, the system was placed on the skin at the         bias±(1.96×standard deviation [SD]).
              heart level. The size of the digital cuff was chosen, and it 
              was placed on the middle finger of the right hand according          5. Comparison of hemodynamic parameters during 
              to the manufacturer’s recommendations. The heart reference           cesarean section 
              system is then zeroed at the midpoint of the right atrium            During cesarean section, 12 defined time points for SBP, DBP, 
              as the reference level. Data for systolic, diastolic, and mean       MBP, heart rate, and CI were obtained from the ClearSight 
              arterial pressures (SBP, diastolic blood pressure [DBP], and         system. These time points were as follows: 1) before the 
              mean blood pressure [MBP]), heart rate, and cardiac index (CI)       surgery, 2) at the time of delivery, 3) at the time of placental 
              obtained using the ClearSight system were extracted from             removal, 4) 5, 5) 10, 6) 15, 7) 20, 8) 25, 9) 30, 10) 40, 11) 
              the EV1000 monitor (Edwards Lifesciences) and registered at          50, and 12) 60 minutes after placental removal. Non-invasive 
              20-second intervals throughout the surgery. Three consecu-           measurements of hemodynamic parameters at each of these 
              tive data points (obtained over 1 minute) were then aver-            12 points were documented, and their medians for each pa-
              www.ogscience.org                                                                                                                327
                                                                   Vol. 65, No. 4, 2022
             tient were compared.                                              tute, AAMI; 2008). The AAMI guidelines state that a paired 
                                                                               reading must have a mean difference of less than 5 mmHg 
             6. Statistical analysis                                           and a mean SD of less than 8 mmHg. In our study, the Bland-
             Continuous variables and categorical variables were ex-           Altman analysis indicated that MBP results measured with 
             pressed as means (ranges) and numbers (%), respectively. To       the ClearSight system met the AAMI standards; therefore, 
             evaluate the accuracy and precision of the ClearSight system      it was apparent that the ClearSight system produced results 
             for BP measurement, compared to intra-arterial catheter,          that were in good agreement with the MBP measurements.
             regression analysis and a Bland-Altman plot with multiple           The variation of MBP obtained from the intra-arterial cath-
             measurements per subject were utilized to compare SBP, DBP,       eter and the ClearSight system are shown Fig. 4A, B. Com-
             and MBP. Estimations were made of the 95% confidence              pared with the MBP measured before the cesarean section, 
             interval of the bias and the LOA, which were calculated as        MBP was significantly decreased after 5 minutes of placental 
             bias±(1.96×SD) [21]. BP obtained from the ClearSight system       removal and returned to the level before the cesarean sec-
             was acceptable if precision and accuracy were less than 5         tion within 50 minutes of placental removal. The variation of 
             mmHg for bias and 8 mmHg for LOA, based on the stan-              hemodynamic parameters obtained from the ClearSight sys-
             dards recommended by the Association for the Advancement 
             of Medical Instrumentation (AAMI) [22]. Statistical analyses 
             were performed using XLSTAT version 2021.2.2 (Addinsoft           Table 1. Characteristics and perioperative data in 21 case per-
             Inc., New York, NY, USA), bell curve for Excel (Social Survey     formed cesarean section under spinal aneshtesia
             Research Information Co., Ltd., Tokyo, Japan), and MedCalc                                                     Value
             statistical software version 20.006 (MedCalc Software Ltd.,       Age (yr)                                  34 (20-42)
             Ostend, Belgium; 2021).                                           Height (cm)                              161 (151-163)
                                                                               Body weight (kg)                        63.8 (51-89)
                                                                                         2
                                                                               BMI (kg/m )                             25.3 (21.6-33.5)
                                                                                                  2
             Results                                                           Body surface area (m )                  1.62 (1.45-1.94)
                                                                               ASA-PS score                               2 (1-3)
             Of the 41 registered patients, 20 were excluded from the          Gestational age (weeks)                 36.6 (30.3-38.7)
             study. Of the 21 cases, 11 (52.4%) were primigravida, eight       Birth weight (g)                       2,680 (1,541-3,485)
             (38.1%) underwent emergency cesarean section, 18 (85.7%)          Apgar score at 1 minute                    8 (1-9)
             had placenta previa, and three (14.3%) had placenta accreta.      Apgar score at 5 minutes                   9 (6-9)
             The characteristics of the maternal and neonatal outcomes         Umbilical artery pH                    7.285 (7.178-7.384)
             and perioperative data are shown in Table 1. The median           Infusion (mL)                          1,500 (750-2,800)
                                                                         2     Autologous blood transfusion (mL)        300 (0-1,200)
             body mass index (BMI) at cesarean section was 25.3 kg/m , 
             and the median operation time was 61 minutes. The median          Red blood cell transfusion (unit)          0 (0-6)
             blood loss was 1,760 mL. Oxytocin was administered to all         FFP transfusion (unit)                     0 (0-8)
             patients.                                                         Blood loss (mL)                        1,760 (900-3,400)
               A total of 1,277 BP measurement pairs were collected            Urine output during operation (mL)       100 (0-500)
             from the 21 cases. The results of the regression analyses of      Operation time (minutes)                  61 (41-89)
             SBP, DBP, and MBP are shown in Fig. 2. The correlation coef-      Anesthesia time (minutes)                 83 (51-133)
             ficients were 0.712, 0.788, and 0.802 for SBP, DBP, and MBP       Phenylephrine (mg)                      0.83 (0.15-1.40)
             respectively. The results of the Bland-Altman plot with mul-      Ephedrone (mg)                            10 (0-25)
             tiple measurements per subject are shown in Fig. 3. The bias      Oxytocin (unit)                           15 (10-30)
             and SD were 8.8±13.4 mmHg for SBP, -6.3±7.1 mmHg for              Plostaglandin F2  (mg)                     0 (0-2)
                                                                                              α
             DBP, and -2.7±8.0 mmHg for MBP. The Association for the           Values are presented as median (ragne).
             AAMI controls the standards for BP equipment for measure-         BMI, body mass index; ASA-PS, American Society of Anesthesiolo-
             ment in human patients (American National Standards Insti-        gists Physical Status; FFP, fresh frozen plasma.
             328                                                                                                       www.ogscience.org
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...Original article obstet gynecol sci https doi org ogs eissn non invasive continuous blood pressure monitoring using the clearsight system for pregnant women at high risks of post partum hemorrhage comparison with during cesarean section takuya misugi phd takashi juri koichi suehiro kohei kitada yasushi kurihara mie tahara akihiro hamuro akemi nakano masayasu koyama takasi mori daisuke tachibana departments obstetrics and gynecology anesthesiology graduate school medicine osaka metropolitan university japan objective this study aimed to investigate accuracy precision obtained by comparing it arterial assess hemodynamic changes methods in patients undergoing was measured invasively an intra catheter placenta previa or accreta measurements these two means were then compared results total measurement pairs collected from under bland altman analysis demonstrated acceptable a bias standard deviation mmhg systolic diastolic median cardiac index levels significantly elevated fetal delivery min...

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