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临床试验/NCT05396924
NCT05396924已完成不适用

Is Rectal Temperature Measurement Quicker in Detecting Hypothermia During Hip Arthroscopy

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年10月13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
116
试验地点
2
主要终点
Is rectal temperature measurement more effective in detecting hypothermia?

研究概览

简要总结

Irrigation fluids used during hip arthroscopy surgery are generally stored at room temperature and are cooler than the core temperature of the patient. They are used abundantly during hip arthroscopy surgery. The aim of this study is to detect local and then general hypothermia that may occur by monitoring the body temperature from the rectal mucosa of patients undergoing hip arthroscopy, using irrigation fluids of different temperatures and comparing it with the temperature measured from the temporal region.

详细描述

This is a prospective randomized controlled study where sequential randomization will be applied to patients; The first patient will be included in the 1st group, and the second patient will be included into the 2nd group, and so on. All patients scheduled for hip arthroscopy in our institution during the defined study period are eligible for inclusion. While room temperature irrigation fluids will be used routinely for Group 1, irrigation fluids heated up to 36-38 degrees will be used for the other group. Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer, whose batteries will be changed every two operations. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined.

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
Double (Participant, Investigator)

盲法说明

Enrolled patients and investigator of final output data will be blinded to the study protocol. Care providers (surgeons, nurses and OR personnel) will not be blinded.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18-50 undergoing hip arthroscopy and willing to participate

排除标准

  • Patients with a previous history of surgery from the same hip
  • Patients with a history of thyroid disease (hypo/hyperthyroidism)

结局指标

主要结局

Is rectal temperature measurement more effective in detecting hypothermia?

时间窗: During the intervention, every 15 minutes.

Throughout the intervention, every 15 minutes, temperature will be measured from the rectum and from the temporal region. Rectal temperature measurements will be compared to temporal measurements in a standardized environment (OR room temperature, noted every 15 min). Comparison will show whether rectal temperature measurement is superior to temporal measurement in detecting intraoperative hypothermia during hip arthroscopy.

次要结局

  • Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy?(During the intervention, every 15 minutes.)

研究者

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

Enejd Veizi, MD

Assistant Professor

Ankara City Hospital Bilkent

研究点 (2)

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