Hypothermia; AnesthesiaNCT03157609
Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
A study testing Thermometry in people with Hypothermia; Anesthesia and Hypothermia Following Anesthesia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Hypothermia; Anesthesia, Hypothermia Following Anesthesia, Children
- What is being tested?
- Thermometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I \& II
- Age: 1d - 16 years
- Elective surgery
- Minimum anaesthesia time of 30 minutes
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Thermometry
- Keywords
- Thermometry, SpotOn
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermometryDevice
Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe
| Study group | Role | What they receive |
|---|---|---|
| Thermometry with SpotOn | Experimental | Application of SpotOn sensor on forehead. Receives: Device: Thermometry |
| Thermometry with oesophageal probe | Active comparator | Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus. Receives: Device: Thermometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of accuracy of SpotOn in children
degrees centigrade
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Nov 2017
- Primary completion15 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Carvalho, MD, Principal investigator, Universitair Ziekenhuis BrusselNadia Najafi, MD, Study chair, Universitair Ziekenhuis BrusselJan Poelaert, PhDMD, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157609
- Sponsor's protocol ID
- SpotOn v 1.0
- Status last verified
- Oct 2017
- First submitted
- 19 Apr 2017
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?
- ClinicalTrials.gov ID
- NCT03157609
- Acronym / sponsor ID
- SpotOn v 1.0
- Keywords
- Thermometry, SpotOn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermometry with SpotOn | Experimental | Device: ThermometryApplication of SpotOn sensor on forehead. |
| Thermometry with oesophageal probe | Active comparator | Device: ThermometryNasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA I \& II
- Age: 1d - 16 years
- Elective surgery
- Minimum anaesthesia time of 30 minutes
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermometryWithin the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe | Device | Thermometry with SpotOn, Thermometry with oesophageal probe |
Primary outcome
Determination of accuracy of SpotOn in children
Time frame: 2 hours
degrees centigrade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Carvalho, MD principal investigator
Universitair Ziekenhuis Brussel
Nadia Najafi, MD study chair
Universitair Ziekenhuis Brussel
Jan Poelaert, PhDMD study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermometry in people with Hypothermia; Anesthesia and Hypothermia Following Anesthesia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of accuracy of SpotOn in children (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.