Study to Evaluate the Accuracy of the New Monitor of Temperature in Comparison With the Consecrated Thermometers by Literature
COMPARATIVE STUDY BETWEEN THE USE OF THE "SPOT ON" THERMOMETER AND THE ORAL AND ESOPHAGEAL THERMOMETERS IN SPINAL AND GENERAL ANESTHESIA
研究概览
详细说明
After approval by the Institutional Research Ethics Committee, the adults and pediatrics participants for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the surgery center at Itapecerica of Serra Hospital. The participants will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, the participants will be included.
Inclusion/exclusion criteria:
Inclusion - adults and pediatrics population that will be submitted to general or spinal anesthesia in the surgery center at Itapecerica of Serra Hospital.
Exclusion:
- The participants that are feverish/present with infectious symptoms
- Refusal of the use of the device by the participants There will be select each groups made up of 70 participants. It will be submitted the adults in two groups, one submitted to general anesthesia and other group submitted to spinal anesthesia and the pediatric group to general anesthesia. The made up for the choice of the thermometer to be to general anesthesia the oral and Spot On thermometers before anesthesia induction, after anesthesia induction the Spot On, and oral, and esophageal thermometers and after surgery in PACU the Spot On and oral thermometer. In group submitted to spinal anesthesia the made up for the choice of the thermometer to be the oral and Spot On thermometers before anesthesia induction, after anesthesia induction and after surgery in PACU the Spot On and oral thermometer.
The thermometer will be used as the moment they will be identified as:
Adult General Group (AGG): the anesthetic procedure will use the spot on thermometer during the pre, intra and post-operative stages and in association with oral during the pre, intra and post-operative stages and the esophagus thermometer during the intra-operative stage.
Adult Spinal Group (ASG): the anesthetic procedure will use the oral and the spot on thermometer in the pre, intra and post-operative stages.
Pediatric General Group (ASG): the anesthetic procedure will use the oral in the pre, intra and post-operative stages and esophageal thermometers in the intra stages and the spot on thermometer during the pre, intra and post-operative stages.
The anesthetic technique will be standard according to the scheduled surgery. The study will assess the participants submitted to elective anesthesia throughout the pre, intra and post-operative stages of all scheduled elective surgeries.
All the participants for elective surgeries lasting 60 minutes or more and/or are scheduled to use any active heating device from the pre, intra and post-anesthetic stages up till the discharge from the post anesthesia recovery room.
The variables to be assessed in the study are:
- Age, gender, weight, height, physical condition according to the American Anesthesiology Association classification;
Oral, SPOT ON, and esophagus temperature measured at the following points:
- Mentrance - entering the room and every 10 min until the anesthesia induction
- Minduction - immediately before induction
- M10, M20, M30 = 10, 20, 30 min after induction and every 10 min till the end of the anesthetic procedure;
- Mpost-0, Mpost-15, Mpost-30, Mdischarge, = 0, 15, 30, and every 15 min till the discharge from post anesthesia recovery room.
- Room temperature of operating room and post anesthesia recovery room (from the participants entrance every 30 minutes to the end of the procedure and discharge to the hospital bed).
Data analysis The data will be tabulated and noted as mean and standard deviation, whenever possible, and observed for normal distribution using the Kolmogorov-Smirnov test (sample size exceeding 50). Nonparametric data will be presented by Mid and distribution boundaries. The values of temperatures are compared by estimation model of generalized equations (GEE) with Bonferroni correction (REF: Guimarães and Hirakata, 2012).
The calculation of the sample consider the participants as his own control (intragroup) and also the comparison between the equipment used (between groups, all three). Using multivariate analysis of variance (ANOVA) repeated measures, with test significance level (alpha) 1% (probability of error type I) and sample size which reduces the probability of type II error (Beta) in 95%, the sample is situated on 120 participants(Ref: Faul et al 2007).
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Ricardo Caio Gracco md De Bernardis
- 电话号码:5511992773523
- 邮箱:rcaiog@yahoo.com.br
研究联系人备份
- 姓名:Ligia Andrade da Silva Telles MD Mathias
- 电话号码:5511993860059
- 邮箱:rtimao@yahoo.com.br
学习地点
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São Paulo
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Itapecerica da Serra、São Paulo、巴西、06854-000
- 招聘中
- Hospital Geral de Itapecerica da Serra
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接触:
- Ricardo Caio Gracco md De Bernardis
- 电话号码:5511992773523
- 邮箱:rcaiog@yahoo.com.br
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接触:
- Ligia Andrade da Silva Telles MD Mathias
- 电话号码:5511993860059
- 邮箱:rtimao@uol.com.br
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
The participants for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the central operating center at the Itapecerica da Serra Hospital.
The participants will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, they will be included.
Inclusion Criteria: adults and pediatrics population that will be submitted to general or spinal anesthesia in the surgery center at Itapecerica of Serra Hospital.
Exclusion Criteria:• Patients that are feverish/present with infectious symptoms and Refusal of the use of the device by the patient
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学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Compare the Spot On with others consecrated thermometers
This study intends to compare the accuracy of the new device(SPOT ON thermometer) with the oral and esophageal in participants submitted to general and spinal anesthesia, in different types of population (pediatric and adult)
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The made up for the choice of the thermometer to be to general anesthesia the oral and new device (Spot On thermometers) before anesthesia induction, after anesthesia induction the Spot On, and oral, and esophageal thermometers and after surgery in PACU the Spot On and oral thermometer.
In group submitted to spinal anesthesia the made up for the choice of the thermometer to be the oral and Spot On thermometers before anesthesia induction, after anesthesia induction the Spot On and oral thermometers and after surgery in PACU the Spot On and oral thermometer.
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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 |
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Compare the Spot On temperature and the consecrated termometer in the perioperative term.
大体时间:30 weeks
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measure the temperature
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30 weeks
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合作者和调查者
出版物和有用的链接
一般刊物
- Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65. doi: 10.1016/j.jtcvs.2006.11.031.
- Kimberger O, Thell R, Schuh M, Koch J, Sessler DI, Kurz A. Accuracy and precision of a novel non-invasive core thermometer. Br J Anaesth. 2009 Aug;103(2):226-31. doi: 10.1093/bja/aep134. Epub 2009 May 29.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 56202616.9.0000.0083
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研究数据/文件
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研究协议
信息标识符:56202616.9.0000.0083信息评论:There you may find the project and all step to get the approval
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