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Forehead thermometer tested for kids under anesthesia

NCT ID NCT03157609

Diagnosis Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special forehead thermometer called SpotOn can accurately measure core body temperature in children during surgery. Researchers enrolled 70 children aged 1 day to 16 years having elective surgery. The goal was to see if this non-invasive sensor could replace more invasive temperature monitoring methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

70 people

The number who actually took part.

Started

Nov 2017

Finished

May 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hypothermia malignant hyperthermia of anesthesia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children Hypothermia following anesthesia Hypothermia; anesthesia

Contacts and locations

Locations

  • Universitair Ziekenhuis Brussel

    Jette, Vlaams-Brabant, 1090, Belgium

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