生体医工学
Online ISSN : 1881-4379
Print ISSN : 1347-443X
ISSN-L : 1347-443X
58 巻, 6 号
選択された号の論文の10件中1~10を表示しています
臨床研究法と該当性判断のためのガイドライン特集論文
  • 中村 英夫, 内 藤 尚, 戸田 英樹, 吉田 正樹
    2020 年 58 巻 6 号 p. 201-211
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    This paper aims to publish an appended table for the Clinical Trials Act to decide the applicability of the law to studies on the development of nursing welfare and rehabilitation devices with mechanical loads in human subjects. Under the Clinical Trials Act, the specified clinical trials must have a medical or dental doctor as a representative. If this limitation applies to challenging exploratory research involving human subjects, the majority of researchers other than medical or dental doctors will face difficulties of pursuing their studies under the law. Significantly, researchers should pay close attention to the delicate issue of whether their studies involve performing “medical practice.” JSMBE announced a guideline for judgment of the applicability to clinical trials involving human subjects last year. The appended table in this paper supports researchers who are interested in nursing welfare and rehabilitation studies, especially those of gait, posture and balance, joint motion, and body pressure, to decide the applicability of the law. The authors, then, consider the appended table to show the standards or assessments for universities and research institutes processing large amounts of evidence and data for publication regarding what must be examined.

研究
  • 中村 有希, 井口 新一, 橘 克典, 海本 浩一
    2020 年 58 巻 6 号 p. 212-218
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    During the long-term use of oxygenator for extracorporeal membrane oxygenation (ECMO), reduced oxygenation capacity due to plasma leakage is very problematic. Currently, plasma leakage is detected by visually judging the color and viscosity of moisture discharged from the gas outlet of the oxygenator. Unfortunately, a better method has not yet been established. Therefore, we evaluated an indirect method for identifying plasma leakage by monitoring the gas inlet pressure using two different oxygenators: BIOCUBE 6000 with an asymmetrically structured membrane and ExcelungNHP with a composite structured membrane. Plasma leakage was simulated by using the surfactant sodium dodecyl sulfate (SDS) that reduces the surface tension. Three SDS solutions at different concentrations were prepared:0% (pure water), 0.1% SDS solution equivalent to the surface tension of plasma in healthy subjects, and 1% SDS solution with lower surface tension than 0.1% SDS solution. During 120 minutes of solution circulation, we evaluated the changes in both the gas inlet pressure and the volume of fluid leaking across the membrane into the gas flow path. In both oxygenators, the gas inlet pressure increased significantly when the 1% SDS solution was circulated. When the SDS concentration increased, the volume of water leaking through the oxygenator membrane increased. After 120 min of circulation, the gas inlet pressure was significantly higher when using BIOCUBE6000 than when using ExcelungNHP (p=0.0008), while the volume of fluid leaking across the membrane into the gas flow path was significantly greater when using ExcelungNHP (p=0.01). Since the gas inlet pressure increased markedly when circulating a 1% SDS solution, which has lower surface tension than that of human plasma, we concluded that monitoring gas inlet pressure changes is a simple method to identify plasma leakage accurately.

  • 本井 幸介, 菅沼 美季, 山越 康弘, 坂井 宏旭, 山越 憲一
    2020 年 58 巻 6 号 p. 219-229
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    In medical and nursing care, body temperature measurement is required for daily health management. In particular, its importance has been well-recognized for the prevention of thermoregulatory failure in patients with spinal cord injuries and for early detection of pneumonia in bedridden elderly. However, commercially available axillary and oral thermometers are cumbersome for such patients as well as for the care staff who operates the devices, because of the need to attach the biological sensor to the patient’s body. This paper describes a new attempt at developing a non-intrusive system for measuring body temperature. While the care staff helps the patient change posture to prevent pressure ulcers, temperature is measured when the bed sheet makes contact with the subject’s body. In this method, three sensor modules, each comprising a thermistor, a resistance-sensitive pressure sensor and a heat insulating material, are installed in the bed sheet and positioned under the subject’s left scapula, celiac plexus, and waist. The body temperature can be estimated from the rate variation of temperature increase immediately after the pressure sensor detects that the subject has laid down on the bed. Comparison of the body temperature obtained from the prototype bed system and that measured by a commercially available axillary thermometer in nine adults (aged 20-98 years) demonstrated that the proposed method may be useful for body temperature measurement. However, improvement in positioning the sensor modules is needed for detailed and continuous analysis of health condition.

  • 郡 慎平, 入野 啓司, 田中 季里, 畑中 由佳, 田地川 勉
    2020 年 58 巻 6 号 p. 230-237
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    In recent years, the number of hemodialysis patients is increasing due to population aging and lifestyle-related diseases, and hemodialysis lowers patients’ quality of life. The technique of hemodialysis was developed based on hemolysis, and it is thought that hemolysis in hemodialysis is induced during discharge by the peristaltic pump. However, studies have not investigated in detail whether hemolysis is instantaneously induced either by the pump or the accumulation of mechanical damage to erythrocytes. In this study, the deformability and degree of hemolysis of erythrocytes in extracorporeal circulation during hemodialysis were measured quantitatively, based on the mechanics of an in vitro model experiment using commercially available blood. In this experiment, the influence of drug administration to patients could be ignored. In the experiment, blood was circulated in a hemodialysis circuit model in which the parameters of flow rate and circulation time were set with reference to hemodialysis conditions in clinical settings. Blood for measurement was sampled from the circuit. The deformability of the sampled erythrocytes was evaluated based on the time constant of shape recovery, which was measured using two methods;the micro-channel and uni-axial stretching methods. Hemolysis was quantified based on absorbance measured using a spectrometer. The results showed that the deformability of erythrocytes remained nearly unchanged over time of hemodialysis when measured by both methods, whereas hemolysis increased in all conditions. These findings indicate that hemolysis is induced instantaneously by the peristaltic pump in the hemodialysis system.

研究速報
  • 苗村 潔, 秋本 和哉
    2020 年 58 巻 6 号 p. 238-242
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    In order to reduce pain quickly during needle insertion for hemodialysis, we proposed and fabricated a novel disposable cooling patch using the heat absorption reaction of dissolving urea in water. We first examined the effect of amount of urea on temperature drop. We then constructed a prototype of the cooling patch using cotton sheets (30mm in length, 25mm in width) to hold urea particles (less than 2mm in diameter) . The prototype was attached to the forearm skin of a healthy subject. When water was dropped on the patch, time transient waveforms of skin temperature and heat flow through the prototype were measured at sampling frequency of 1Hz. Experimental results showed that skin temperature decreased to 25℃ under the conditions that 2mL of water was dropped on the cotton sheet with 0.9 grams or 0.015mol of urea particles On the other hand, two minutes were required to reach the minimum temperature. The method of dropping water affected the minimum skin temperature. Further study is needed to examine the feasibility of using smaller urea particles, and to find the appropriate method of adding water on the cooling patch in the hospital.

  • 上村 匠, 金山 義男, 北 村 寛, 中島 一樹
    2020 年 58 巻 6 号 p. 243-247
    発行日: 2020/12/10
    公開日: 2021/03/25
    ジャーナル フリー

    A bladder diary records the urination time and is used for the diagnosis of patients with urination disorders. We have developed a non-contact uroflowmeter system to record urination time. In this study, we compared the urination time recorded by the uroflowmeter system, which is used as a standard, and that recorded manually in a bladder diary. Time differences between the two methods of recording urination time were evaluated in 645 urinations in healthy subjects (Subj group) and 102 urinations in hospitalized patients (P_Subj group). Individuals in the Subj group confirmed the urination time using a radio controlled clock, while those in the P_Subj group confirmed the time using their own clock according to standard medical care procedures. The differences in urination time recorded manually by participants in the P_Subj group were due to human error, and the time differences were significantly longer than those in the Subj group. These results suggest that the uroflowmeter system will be useful for monitoring urination time for the bladder diary.

生体医工学シンポジウム2020
訃報
feedback
Top