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

NCT03157609 | Completed

• 1 other identifier: SpotOn v 1.0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Anesthesia; Hypothermia Following Anesthesia; Children

Keywords

Thermometry; SpotOn

Outcome Measures

Primary Outcomes (1)

• Determination of accuracy of SpotOn in children

  degrees centigrade

  2 hours

Study Arms (2)

Thermometry with SpotOn

EXPERIMENTAL

Application of SpotOn sensor on forehead.

Device: Thermometry

Thermometry with oesophageal probe

ACTIVE COMPARATOR

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

Device: Thermometry

Interventions

Thermometry DEVICE

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

Thermometry with SpotOn; Thermometry with oesophageal probe

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Thermometry

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hugo Carvalho, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Nadia Najafi, MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

• Jan Poelaert, PhDMD

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: use of a third person (blinded to study design, population and statistics) which will extract data blindly from the hospital anaesthesia electronic database
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 17, 2017
• Study Start: November 15, 2017
• Primary Completion: April 15, 2018
• Study Completion: May 1, 2018
• Last Updated: November 18, 2025

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)