Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Determination of accuracy of SpotOn in children
研究概览
简要总结
The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry sensor in measuring core temperature in the paediatric population in the perioperative period.
详细描述
Temperature regulation in the perioperative period is of primordial importance in paediatric population - a particularly sensitive group for thermal variations.
In fact, infants lose a significantly high percentage of their core heat from skin perspiration in comparison to adults (where it approximates roughly 10%). This percentage can go up to 20% in premature infants and relates to the fact that cutaneous heat loss is "grosso modo" proportional to body surface area.
This higher thermal vulnerability is aggravated during the perioperative period, where body exposure to the cold operating room environment is increased, and where anaesthetic interventions impair the compensatory mechanisms to the extent of being unable to sufficiently increase heat production to compensate for hypothermia.
An alternative thermometry method called Zero-heat-flux was developed in the 1970's in an attempt to compensate for the limitations of pure skin temperature, while maintaining its practical character. It is based on the principle that the temperature 1-2 cm below skin surface reasonably approximates core temperature. In order to measure it, it uses 4-layered probe, with the following inside-out structure: patient temperature thermistor, insulating foam layer, heating (flex) circuit, and insulating foam. A servo-controlled system actively warms the probe circuit to the point where, theoretically, temperature equilibrium is achieved between the skin and deeper structures and there is zero heat transfer to the surrounding areas. This concept is commonly exemplified as the creation of a vertical isothermal tunnel between the skin surface and lower dermal layers. Assuming a good tissue perfusion, dermal temperature will reasonably approximate core temperature.
Although a systematic adult population validation is on its way, no data on the paediatric patients exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
use of a third person (blinded to study design, population and statistics) which will extract data blindly from the hospital anaesthesia electronic database
入排标准
- 年龄范围
- 1 Day 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I & II
- •Age: 1d - 16 years
- •Elective surgery
- •Minimum anaesthesia time of 30 minutes
排除标准
- •Fragile skin state in the forehead
- •Know allergy to probe adhesive
- •Maxillofacial trauma or lesions
- •Procedures impeding proper use of SpotOn™ sensor (mostly maxillo-facial)
- •Abnormal oesophageal anatomy/gastroesophageal procedures.
- •Coagulopathy
- •Neurologically impaired children with abnormal thermoregulation
- •Extensive Haemodynamic instability
- •Need for Vasopression
- •Procedures associated with extended use of rinsing fluids (abdominal/thoracic lavages)
- •Thoracoscopic/thoracotomic procedures (oesophageal probe cooling)
- •Need for use of "over body" forced air warming systems
- •Malignant Hyperthermia or family history of malignant hyperthermia
- •Fever / Infectious patient
- •All conditions that might be judged to alter skin perfusion in an abnormal way
- •Anatomical variants (overt hydrocephalus …)
- •Calibration/device failure
研究组 & 干预措施
Thermometry with SpotOn
Application of SpotOn sensor on forehead.
干预措施: Thermometry (Device)
Thermometry with oesophageal probe
Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus.
干预措施: Thermometry (Device)
结局指标
主要结局
Determination of accuracy of SpotOn in children
时间窗: 2 hours
degrees centigrade
次要结局
未报告次要终点
