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临床试验/NCT05302323
NCT05302323已完成不适用

Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

Neslihan Ilkaz2 个研究点 分布在 2 个国家目标入组 77 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
tympanic and esophageal body temperature measurement between two groups

研究概览

简要总结

This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.

详细描述

After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.

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 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 1-2-3
  • Patients with abdominal surgery
  • Patients receiving general anesthesia

排除标准

  • Unwanted to participate in the study
  • Patients over 70 years of age
  • Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
  • Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
  • Presence of infectious fever
  • ASA 4 and above
  • Emergency surgery
  • Patients receiving pre-operative chemotherapy
  • Having problems such as tearing and perforation of the covers during the work.
  • Patients being hyperthermic in the intraoperative process

结局指标

主要结局

tympanic and esophageal body temperature measurement between two groups

时间窗: throughout the operation (min.2 hours) (max. 6 hours)

Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.

次要结局

未报告次要终点

研究者

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

Neslihan Ilkaz

Operating Room Nurse, PhD, RN

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (2)

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