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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03157609
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : July 2, 2018
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Hypothermia; Anesthesia Hypothermia Following Anesthesia Children Device: Thermometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Primary Purpose: Other
Official Title: Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : May 1, 2018

Arm Intervention/treatment
Experimental: Thermometry with SpotOn
Application of SpotOn sensor on forehead.
Device: Thermometry
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.
Device: Thermometry
Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe

Primary Outcome Measures :
  1. Determination of accuracy of SpotOn in children [ Time Frame: 2 hours ]
    degrees centigrade

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03157609

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Universitair Ziekenhuis Brussel
Jette, Vlaams-Brabant, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
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Principal Investigator: Hugo Carvalho, MD Universitair Ziekenhuis Brussel
Study Chair: Nadia Najafi, MD Universitair Ziekenhuis Brussel
Study Director: Jan Poelaert, PhDMD Universitair Ziekenhuis Brussel

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Responsible Party: Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel Identifier: NCT03157609     History of Changes
Other Study ID Numbers: SpotOn v 1.0
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms