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

Primary Purpose

Hypothermia; Anesthesia, Hypothermia Following Anesthesia, Children

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Thermometry
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypothermia; Anesthesia focused on measuring Thermometry, SpotOn

Eligibility Criteria

1 Day - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thermometry with SpotOn

Thermometry with oesophageal probe

Arm Description

Application of SpotOn sensor on forehead.

Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus.

Outcomes

Primary Outcome Measures

Determination of accuracy of SpotOn in children
degrees centigrade

Secondary Outcome Measures

Full Information

First Posted
April 19, 2017
Last Updated
June 28, 2018
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03157609
Brief Title
Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
Official Title
Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia, Hypothermia Following Anesthesia, Children
Keywords
Thermometry, SpotOn

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermometry with SpotOn
Arm Type
Experimental
Arm Description
Application of SpotOn sensor on forehead.
Arm Title
Thermometry with oesophageal probe
Arm Type
Active Comparator
Arm Description
Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus.
Intervention Type
Device
Intervention Name(s)
Thermometry
Intervention Description
Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe
Primary Outcome Measure Information:
Title
Determination of accuracy of SpotOn in children
Description
degrees centigrade
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Carvalho, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadia Najafi, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, PhDMD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams-Brabant
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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