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Non-invasive Perioperative Hb Monitoring in Spinal Surgery

2018年4月18日 更新者:Tehran University of Medical Sciences

Evaluating and Comparing the Accuracy of Non-invasive Hemoglobin Monitoring by Spectrophotometry With and Without Digital Nerve Block in Patients Undergoing Spinal Surgery in Sina Hospital During 2016-2017

The decision to transfuse or not to transfuse blood products is one of the main issues in patients undergoing surgery.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin.

However, one of the main concerns regarding this method is its accuracy. Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, use of digital nerve blocks proposed to increase its accuracy.

This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing spinal surgery.

研究概览

详细说明

The decision to transfuse or not to transfuse blood products is one of the main issues in healthcare systems. Timely transfusion of blood to a patient bleeding, either due to the surgery or because of the trauma, can prevent tissue hypoxia and ischemia in vital organs. However, transfusion of blood products should be done carefully and cautiously due to the potential complications of transfusions, and also because of the cost of providing blood products 1, 2, 3. Hence, during surgeries, hemoglobin level has a vital role in the diagnosis and management of patients with anemia.

The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin (SpHb Masimo Rainbow Co-oximeter). This procedure is applied by a digital probe and allows physicians to monitor hemoglobin levels continuously. 4, 5, 6 However, one of the main concerns regarding this method is its accuracy. Actually, the difference between the measured hemoglobin level and the actual hemoglobin level of the patient, might make it impossible for physicians to decide with sufficient confidence3.

From the time that SpHb has been available in operating rooms, various studies have evaluated its accuracy. While its accuracy has been reported relatively acceptable (mean difference is about 1-1.5 g/dl comparing to the lab data),4 there are still concerns regarding this issue. Furthermore, it is not clear whether this difference would remain the same during the surgery or not. Because blood transfusion is rarely needed when the hemoglobin level of patient is higher than 10g/dl during the surgery. Also, blood transfusion becomes obviously necessary if hemoglobin levels drop to 6g/dl or lower during the surgery. Therefore, the accuracy of the tool in assessing hemoglobin levels at this critical interval (6-10g/dl) is of greater importance.6,7 Experimental studies have confirmed that accuracy could change in different hemoglobin levels5,8, and with the passage of time.9 In addition, it has been reported that after significant blood loss or even following injection of blood, the average difference between SpHb and laboratory might change, as well. 5,8 Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, methods that enhance blood circulation in the organ (including local heating of the organ and use of digital nerve blocks (DNB), proposed to increase its accuracy.10, 11 In a study conducted in 2012 by Miller et al. on 20 patients undergoing spinal surgery, DNB was performed using lidocaine. The differences between SpHb and lab hemoglobin were recorded first after injection, and then at almost hourly intervals. These differences were compared to data from another study without DNB. Thirty seven percent of data in the intervention group and 12% of data in the control group was considered as "very accurate". Results of this study showed that DNB increased perfusion indices and SpHb accuracy.10 Following the previous study, Miller et al. carried out a study in 2014 to compare the effects of DNB with lidocaine and bupivacaine on 12 healthy volunteers. DNB was performed on two identical fingers on both hands of the volunteers. Lidocaine was used on one hand and bupivacaine on the other one. Results of this study showed that both lidocaine and bupivacaine raised the perfusion indices and temperatures of the fingers. The duration and extent of the rise in temperature were more for bupivacaine, and there was a direct correlation between changes in perfusion index and those in SpHb.11 Since, the previous study data had been gathered from healthy individuals, this study aims at investigate the effects of DNB on the accuracy SpHb in patients undergoing surgery.

研究类型

介入性

注册 (实际的)

23

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria: All patients 18 years of age or older, admitted to Sina hospital to have spinal surgery, whose surgery is not an emergency, are included in the study. Moreover, the patients must be in grade 2 or lower according to the ASA Physical Status Classification, and volunteer to participate in the study.

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Exclusion Criteria: Patients who are going to have an emergency surgery are excluded from the study. Also patients with grade 3 ASA or higher, or the ones suffering from anatomic or vascular disorders that cause problems in attaching the SpHb sensor, are excluded from the study.

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学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Digital nerve block in left hand
Patients in this group will receive DNB in left hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
实验性的:Digital nerve block in right hand
Patients in this group will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
accuracy of SpHb
大体时间:At the start of the operation, once every 1.5 hours during the operation till its end
in each patient, Sphb values will be documented for both hands. Also, the arterial blood sample (lab Hb) will be sent to the laboratory. The difference between two measure in each hand (with or without DNB) shows the accuracy of Sphb for each hand.
At the start of the operation, once every 1.5 hours during the operation till its end

次要结果测量

结果测量
措施说明
大体时间
Perfusion index (PI)
大体时间:At the start of the operation, once every 1.5 hours during the operation till its end
In each patient, PI value of hand with DNB will be compared to PI measure in the other hand.
At the start of the operation, once every 1.5 hours during the operation till its end
Pleth Variability Index (PVI)
大体时间:At the start of the operation, once every 1.5 hours during the operation till its end
In each patient, PVI value of hand with DNB will be compared to PI measure in the other hand.
At the start of the operation, once every 1.5 hours during the operation till its end

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

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一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月4日

初级完成 (实际的)

2017年10月1日

研究完成 (实际的)

2018年1月1日

研究注册日期

首次提交

2016年9月15日

首先提交符合 QC 标准的

2016年9月15日

首次发布 (估计)

2016年9月21日

研究记录更新

最后更新发布 (实际的)

2018年4月20日

上次提交的符合 QC 标准的更新

2018年4月18日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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Digital nerve block with bupivacaine的临床试验

3
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