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临床试验/NCT04011462
NCT04011462已完成不适用

Perioperative Normothermia: Temperature and Prewarming Methods

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer

研究概览

简要总结

The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

详细描述

The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and over at the time of data collection
  • Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour

排除标准

  • Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
  • Patients submitted to video laparoscopic or minimally invasive surgeries

研究组 & 干预措施

Prewarming 20 minutes

Experimental

prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.

干预措施: prewarming 20 minutes (Device)

Prewarming 30 minutes

Experimental

prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.

干预措施: prewarming 30 minutes (Device)

Standard care

No Intervention

warming with cotton sheet and blanket for 20 minutes.

结局指标

主要结局

Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer

时间窗: Perioperative period

Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to number of patients with temperature below 36 degrees measured by the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa de Brito Poveda

Professor

University of Sao Paulo

研究点 (2)

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