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

June 28, 2018 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Jette, Vlaams-Brabant, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermometry with SpotOn
Application of SpotOn sensor on forehead.
Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe
Active Comparator: Thermometry with oesophageal probe
Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus.
Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of accuracy of SpotOn in children
Time Frame: 2 hours
degrees centigrade
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hugo Carvalho, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Nadia Najafi, MD, Universitair Ziekenhuis Brussel
  • Study Director: Jan Poelaert, PhDMD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SpotOn v 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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