跳至主要内容
临床试验/NCT02993003
NCT02993003撤回不适用

Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study

The Cleveland Clinic2 个研究点 分布在 1 个国家开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
nasopharyngeal and esophageal temperatures

研究概览

简要总结

Core temperature is of greatest interest in terms of temperature monitoring as it is thought to represent the temperature of the vessel-rich groups that are instrumental in thermoregulatory control. The nasopharynx is among the recommended temperature monitoring sites for core body temperature. It is the part of the pharynx that lies above the soft palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures are accurate in adults when probes are inserted between 10 and 20 cm.

The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants and children. While some data suggest that anthropometric measurements are well correlated with endoscopic measurements in infants based on weight, the accuracy of temperature measurements at these and other distances has yet to be quantified. The investigators thus propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature proves that best approximate core temperature as measured in the distal esophagus in infants and children of various sizes. The comparison site will be the distal esophagus since there is broad consensus that the distal third of the esophagus it at core-body temperature.

For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm.

Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated increment for each age group and will be equilibrated for 5 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of measurement will depend on the initial depth of insertion, with measurements continuing until only 2 centimeters remain in the nostril.

研究设计

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

入排标准

年龄范围
7 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elective non-cardiac surgery in children to last at least 1.5 hours;
  • Supine position anticipated;
  • General endotracheal anesthesia.

排除标准

  • Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral or facial surgery;
  • History of genetic or congenital anomalies leading to facial dimorphism;
  • History of recent substantive epistaxis or suspected bleeding disorder;
  • Therapeutic-dose anti-coagulation;
  • Contraindication to esophageal temperature probe insertion (i.e., esophageal varices, congenital anomalies).

研究组 & 干预措施

Children between 7 months and 12 months

Other

nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm

干预措施: Nasopharyngeal probe (Device)

children between 1 and 5 years

Other

nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm

干预措施: Nasopharyngeal probe (Device)

children between 6 and 12 years

Other

a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm

干预措施: Nasopharyngeal probe (Device)

结局指标

主要结局

nasopharyngeal and esophageal temperatures

时间窗: up to 2 hrs during surgery

nasopharyngeal and esophageal temperatures at each depth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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