跳至主要内容
临床试验/NCT07455695
NCT07455695已完成不适用

Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2023年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
285
试验地点
1
主要终点
Change in Body Temperature (ΔT) Before and After MRI

研究概览

简要总结

Magnetic resonance imaging (MRI) is widely used in pediatric patients and frequently requires sedation or general anesthesia. Both sedation and MRI-related environmental factors may influence thermoregulation. This prospective observational study aimed to evaluate body temperature changes in children undergoing MRI under sedation and to identify factors associated with these changes. A total of 285 pediatric patients (ASA physical status I-III) were included. Tympanic body temperature was measured immediately before sedation and after completion of MRI, and the temperature difference (ΔT) was calculated. Demographic, clinical, and environmental variables were analyzed to determine predictors of temperature change.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age <18 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.
  • Written informed consent obtained from parent.

排除标准

  • Age ≥18 years.
  • ASA physical status IV-V.
  • Known allergy to anesthetic medications used for sedation.
  • Unstable vital signs prior to MRI.
  • Fever (body temperature ≥37.5°C) before MRI.
  • Severe pulmonary or cardiovascular comorbidities.
  • Requirement for advanced airway management (laryngeal mask airway or endotracheal intubation).
  • Refusal or absence of parental consent.

结局指标

主要结局

Change in Body Temperature (ΔT) Before and After MRI

时间窗: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)

The difference between tympanic body temperature measured immediately before sedation and immediately after completion of MRI (post-MRI minus pre-MRI temperature), expressed in degrees Celsius (°C).

次要结局

  • Change in Tympanic Body Temperature (ΔT)(From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).)
  • Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)(From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes))

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmet Murat Gul

Specialist

Ankara Etlik City Hospital

研究点 (1)

Loading locations...

相似试验

Temperature Changes During Sedated Pediatric... | 临床试验