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Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?

Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03157609
Enrollment
70
Registered
2017-05-17
Start date
2017-11-15
Completion date
2018-05-01
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Hypothermia; Anesthesia, Hypothermia Following Anesthesia

Keywords

Thermometry, SpotOn

Brief summary

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.

Detailed description

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. Considering the practical and non-invasive character of this skin surface probe, as well as the abovementioned thermal sensitivity concerns on the paediatric population, it seems that, should the probe indeed prove to be accurate in this age range, it can definitely contribute to the improvement of the perioperative temperature management in children.

Interventions

Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

use of a third person (blinded to study design, population and statistics) which will extract data blindly from the hospital anaesthesia electronic database

Eligibility

Sex/Gender
ALL
Age
1 Days to 16 Years
Healthy volunteers
No

Inclusion criteria

* ASA I & II * Age: 1d - 16 years * Elective surgery * Minimum anaesthesia time of 30 minutes

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Determination of accuracy of SpotOn in children2 hoursdegrees centigrade

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026