Linear Infl ation Technology Non-invasive Blood Pressure Measurement. inibp Case Report Experiences in OR

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Linear Infl ation Technology Non-invasive Blood Pressure inibp Case Report Experiences in OR

C ONTENTS Introduction 2 Technological Description of inibp inibp advantages 2 inibp technology adapts to each patient situation and condition 4 [Case1] Laparoscopic assisted distal gastrectomy 5 [Case 2] Pelvic lymphadenectomy, para-aortic lymphadenectomy 6 [Case 3] Laparoscopic resection of descending colon 7 [Case 4] Radical prostatectomy 8 [Case 5] Laparoscopic uterine myomectomy 9 Discussion 1

inibp Case Report Experiences in OR Introduction inibp is Nihon Kohden's new non-invasive blood pressure algorithm using linear inflation technology. This case report, which describes the perioperative use of inibp, is designed to help clinicians and healthcare professionals understand and appreciate the performance characteristics of inibp, including the advantages and limitations of the. Technology Description of inibp inibp advantages Non-invasive blood pressure (NIBP) is commonly used as an important vital sign to evaluate patients' hemodynamic status. In the traditional oscillometric NIBP using the conventional step-deflation method, a cuff placed on the patients' limb is rapidly inflated to a target pressure greater than systolic, and then deflates step-wise while sensing the oscillations of the arterial wall created by pulsatile blood flow through the artery. On the other hand, inibp inflation method completes the while inflating a cuff. Therefore, when compared to the conventional method, the inibp time is shorter (Figure 2) and target inflation pressure is lower 1, maximizing patient comfort while preserving the accuracy of this important parameter. The conventional step-deflation method sets the target inflation pressure based on the previous systolic blood pressure (). When the patient's blood pressure increases compared to previous s, the target inflation pressure may be set to a level which is insufficient for the. In these cases, another inflation-deflation cycle is required, and may be repeated, increasing both the time and potential for patient discomfort (Figure 3.a). When the patient's blood pressure has dropped since the previous, the target inflation pressure is set significantly above the previous systolic pressure, which again leads to longer time and excessive pressure applied to the patient (Figure 3.b). With inibp technology from Nihon Kohden, the algorithm effects a slow inflation of a cuff while simultaneously detecting oscillations, then deflates the cuff as soon as is determined. The advantages of inibp are best demonstrated when patient's blood pressure is varying, for example during surgery. As inibp inflates while sensing blood pressure variation, it can complete the in a shorter amount of time without applying excessive and unnecessary pressure to the patient. Cuff pressure Cuff pressure oscillation oscillation Figure 1 Comparison of the inibp inflation method to the conventional deflation method (Upper) The conventional step-deflation method: A cuff is rapidly inflated to a target inflation pressure, and then deflated step-wise while sensing oscillations. (Lower) inibp inflation method: A cuff is slowly inflated to a lower inflation pressure while simultaneously sensing oscillations. 25 sec shorter inibp method Frequency (Number) 15 inibp 13.±2.3 sec (avg) method 32.7±13.6 sec (avg) 5 5 1 15 25 3 35 45 5 55 65 7 time (sec) Onodera J. et al. Validation of inflationary non-invasive blood pressure monitoring in adult surgical patients. J Anesth. 11 Feb;25(1):127-3. Figure 2 Histogram of time of inibp inflation method and deflation method 323 data collected in 64 cases in operating room were used to compare time of inibp inflation method and conventional deflation method. 2

elevated to mmhg inibp can complete the in a shorter amount of time as it inflates the cuff while sensing blood pressure variation and detecting oscillations, whereas the deflation method needs to repeat the inflation-deflation cycle when the target inflation pressure, based on previous systolic pressure s are comparatively low. Cuff pressure (mmhg) 3 25 15 5 Pressure still too low Pressure too low 1mmHg 21mmHg 25mmHg inibp completes as soon as is determined Shorter time inibp method completes 1 3 5 Figure 3.a. inibp in blood pressure elevation Time (sec) BP 9:3 1:3 11:3 12:3 13:3 Cuff pressure (mmhg) 3 25 Lower pressure 15 13mmHg 2mmHg inibp completes as soon as is determined inibp method completes 5 Shorter time 1 3 5 Figure 3.b. inibp in blood pressure drop Time (sec) dropped to mmhg inibp inflates the cuff to only slightly above the while detecting oscillations and completes the in a shorter amount of time, in comparison with the deflation method, which inflates a cuff based on a pre-determined target pressure that often significantly exceeds actual, leading to longer times with the increased potential for patient discomfort. Figure 3 inibp in elevation and drop in blood pressure 3

inibp Case Report Experiences in OR inibp technology adapts to each patient situation and condition inibp automatically switches its mode to step-deflation in situations where it cannot determine an accurate blood pressure value with inflation method because of factors related to environment and patient's physiology. Also, inibp automatically employs the deflation method when signal reliability of the blood pressure reading, based on the blood pressure determined while inflating, is poor (Figure 4). Examples of these situations and conditions are shown below. When these conditions improve, inibp will change the mode to the inflation method. Based on the analysis of actual clinical data, about % of s in the Operating Room (OR) and 7% of in the Emergency Room (ER) were performed with the inflation method 2. Factor related to environment Cuff and/or tube are not secure and stable because of body motion or contact with the cuff/tube Cuff is either too tight or too loose Non-recommended cuff or an older cuff with worn Velcro is used Improperly sized cuff for the patient Cuff placed over thick clothing Factor related to patient s physiology Frequent arrhythmia Patient has weak pulsation due to shock or has extremely low blood pressure ( lower than mmhg or lower than 3 mmhg) Patient has pulse waves with low amplitude (small pulse wave) Slow pulse rate ON OFF Inflate a cuff Inflate a cuff until reaching a target cuff pressure Detect oscillations Deflate step-wise Calculate,, and MAP Unable to calculate Detect oscillations Determine the reliability Low reliability Calculate,, and MAP Unable to calculate Display, and MAP Determine the reliability Low reliability Display, and MAP completes completes No NIBP reading provided Figure 4 flow of linear inflation technology non-invasive blood pressure inibp 4

[Case 1] Laparoscopic assisted distal gastrectomy Disease : Stomach cancer : General anesthesia with epidural block (volatile anesthetic) Patient : 68 years old male, height 17 cm, weight 81 kg. Cuff on left arm time : 8:55 15:5 Surgical time : 9:37 15:25 9: 1: 11: 12: 13: 14: 15: 16: Pulse rate BP 1 1 1 B A C PR time (sec) Number of 13 time (sec) Average Minimum Maximum 14.7 13.9 16.9 - - - In this case, a minimally-invasive procedure was performed. Blood pressure increased approximately 3 mmhg between the second ( A ) and third ( B ) NIBP, then decreased 25 mmhg between the third ( B ) and fourth ( C ). In cases such as this where blood pressure varies significantly, the conventional deflation method is more likely to repeat the inflation-deflation cycle or set the target inflation pressure too high, leading to longer times. This case shows that inibp successfully completed all s with the inflation method even in a patient with significant blood pressure variation within a short time. [Feedback from anesthesiologist] "I'm curious if NIBP will perform in patients with arrhythmia (e.g. AF, bigeminy or trigeminy). The inibp time appears to be shorter compared to the conventional method when used in patients with normal sinus rhythm." 5

inibp Case Report Experiences in OR [Case 2] Pelvic lymphadenectomy, para-aortic lymphadenectomy Disease : Ovary cancer : General anesthesia with epidural block (volatile anesthetic) Patient : 47 years old female, height 161 cm, weight 56 kg. Cuff on left arm time : 1:55 17:6 Surgical time : 11:21 16:39 Pulse rate 1 BP 1 1: 11: 12: 13: 14: 15: 16: 17: E 1 A B C D PR time (sec) Number of 1 time (sec) Average Minimum Maximum 12.2 11. 14.2 4 51.5 44.6 57.3 In the first half of the surgery (beginning of surgery until approximately 14:3), the cuff frequently detected noise caused by touching the cuff, so the inibp algorithm did not determine blood pressure while inflating the cuff and switched its mode to the deflation method ( A B C and D ). As shown in this case, inibp automatically changes its mode depending on the situation in order to provide reliable readings. This case also shows that inibp can complete the with the inflation method in a shorter period of time in cases when the patient's blood pressure increases to 43 mmhg ( E ), where the conventional method will require repetitive inflationdeflation cycles. [Feedback from anesthesiologist] The time of inibp did not appear to be significantly shorter compared to the conventional method. 6

[Case 3] Laparoscopic resection of descending colon Disease : Descending colon cancer : General anesthesia with epidural block (volatile anesthetic) Patient : 72 years female, height 151 cm, weight 74.5 kg. Cuff on left arm time : 9:5 15:49 Surgical time : 1: 15:3 Pulse rate 1 BP 1 9: 1: 11: 12: 13: 14: 15: 16: 1 1 1 PR time (sec) Number of 13 time (sec) Average Minimum Maximum 14.2 1.8 29.7 11 58.6 49..5 The patient had low amplitude pulse wave and her blood pressure was relatively low ( -9/ 3-5 mmhg) during surgery. When the amplitude of oscillations is lower than a threshold, where it cannot determine an accurate blood pressure value with inflation mode, inibp determines NIBP value with the deflation mode instead of the inflation mode. In this case, the amplitude of patient's pulse wave frequently ranged about the threshold, so inibp provided half of the readings with the deflation method. However, inibp completed the in a shorter period of time with the inflation method even when blood pressure dropped immediately after the anesthesia induction and when blood pressure elevated after the end of surgery and at awakening of the patient. [Feedback from anesthesiologist] It appears that the inibp time was half the conventional NIBP time. 7

inibp Case Report Experiences in OR [Case 4] Radical prostatectomy Disease : Prostate cancer : General anesthesia with epidural block (volatile anesthetic) Patient : 65 years old male, height 168 cm, weight 68 kg. Cuff on left arm time : 11:5 17:25 Surgical time : 12:14 16:52 Pulse rate 1 BP 1 11: 12: 13: 14: 15: 16: 17: 1 PR time (sec) Number of 13 time (sec) Average Minimum Maximum 13.3 12. 16.2 - - - In this case, all s throughout the surgery, from the anesthesia induction through patient awakening, were performed with the inflation mode under the condition of varying blood pressure. [Feedback from anesthesiologist] I was impressed by the speed of the. inibp can be convenient because of the shorter time, which may not be essential. 8

[Case 5] Laparoscopic uterine myomectomy Disease : Uterine myoma : General anesthesia (volatile anesthetic) Patient : 37 years old female, height 151 cm, weight 53 kg. Cuff on left arm time : 8:38 12:43 Surgical time : 9:8 12:25 Pulse rate 1 8: 9: 1: 11: 12: 13: BP 1 1 A B PR time (sec) Number of 7 time (sec) Average Minimum Maximum 13.9 12.8 14.6 2 39.4 39.2 39.6 After the start of the surgery, the deflation method was used for the third ( A ) and fourth ( B ) because of noise caused by patient's body motion. Subsequently, inibp completed all s with the inflation method throughout the surgery. This case demonstrates that inibp automatically switches its mode to the step-deflation method in a situation where it cannot determine an accurate blood pressure value with the inflation method due to factors that can affect. [Feedback from anesthesiologist] inibp's advantage of being able to measure while inflating allows for shorter time, which can make the more comfortable for patients. 9

inibp Case Report Experiences in OR Discussion Nihon Kohden's Linear Technology, Non-invasive Blood Pressure, inibp, determines blood pressure by detecting oscillations during the initial inflation of the cuff. Compared to the conventional method, inibp can provide accurate blood pressure readings in less time without applying excessive pressure to the patient, leading to maximized comfort for patients. inibp allows clinicians to accurately measure blood pressure immediately and when this critical vital sign is needed the most, especially during dynamic blood pressure changes during surgery. Nihon Kohden is hopeful that you find this report useful to understand the performance of inibp. Please contact us with your ideas and suggestions on how this technology might benefit you and your patients. Reference 1 Jun Onodera, Yoshifumi Kotake et al. Validation of inflationary non-invasive blood pressure monitoring in adult surgical patients. J Anesth, 11;25:127-13. 2 Junichi Sasaki, Shingo Hori. Validation of inflationary non-invasive blood pressure monitoring in emergency room patients. Poster presentation at the 34th International Symposium on Intensive Care and Emergency Medicine. The data shown in this Case Report was provided by Department of Anesthesiology, Toho University Ohashi Medical Center. 1

inibp Case Report Experiences in OR 798 SP64-7 14.8. CLB.E. Printed in Japan