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临床试验/NCT03057886
NCT03057886Unknown不适用

COMPARATIVE STUDY BETWEEN THE USE OF THE "SPOT ON" THERMOMETER AND THE ORAL AND ESOPHAGEAL THERMOMETERS IN SPINAL AND GENERAL ANESTHESIA

Ricardo Caio Gracco De Bernardis1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2018年7月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
210
试验地点
1
主要终点
Compare the Spot On temperature and the consecrated termometer in the perioperative term.

研究概览

简要总结

This study compares the use of the "SPOT ON" thermometer with the oral, esophageal in participants submitted to general and the oral thermometer to spinal anesthesia, from the pre op, intra and post op stages, evaluating the accuracy of this new monitor against the already consecrated one by literature. The Investigators will analyze in three different types of anesthesia (general, spinal and pediatric population).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults and pediatrics population that will be submitted to general or spinal anesthesia in the surgery center at Itapecerica of Serra Hospital.

排除标准

  • Patients that are feverish/present with infectious symptoms and Refusal of the use of the device by the patient

结局指标

主要结局

Compare the Spot On temperature and the consecrated termometer in the perioperative term.

时间窗: 30 weeks

measure the temperature

次要结局

未报告次要终点

研究者

发起方
Ricardo Caio Gracco De Bernardis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ricardo Caio Gracco De Bernardis

PHD

Faculdade de Ciências Médicas da Santa Casa de São Paulo

研究点 (1)

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