Magnetic Field ExposureHOT-MRNCT04317378
Increase in Temperature in Children Undergoing MRI
An observational study of Magnetic Field Exposure and Temperature Change, Body, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
An increasing number of children undergo Magnetic Resonance Imaging (MRI). In MRI, radio waves and magnetism are used to form images of the body's interior, to diagnose and monitoring diseases in children. Many children are sedated to be able to collaborate with the MRI procedure. Read more about this study
- Who is it for?
- Ages 12 weeks to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Field Exposure, Temperature Change, Body, Children, Only
- What is being tested?
- Braun thermoscan /, IRT 6520
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2020to 28 Aug 2020
- Phase
- Observational
- 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 12 weeks to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 12 weeks to 12 years of age undergoing MRI procedure with the assistance of anesthesiologists from the Neuroanesthesiology Clinic may be included. Oral and written consent from the parent or relatives of the child will be obtained in accordance with science ethical rules.
Who may be able to join
- Age from 12 weeks to 12 years
- Children undergoing MRI scans with the help of anesthesia staff from the Neuroanesthesiology Clinic under general anesthesia or awake
- The children are recruited via prescriptions or the anesthetist immediately before scanning and outside the MRI room. All children who meet the criteria for MRI scan can be included. Acute MRI children, children admitted to intensive care and children who came is directly from the operation if consent is obtained.
Who cannot join
- Inability at present. and relatives to speak and understand Danish or English. An authorized interpreter may be used for a family that does not have a Danish background and only if written and oral information material is understood otherwise the patient is excluded
- No consent to the study
- Anatomically not possible to measure ear temperature
- Temperature above 39 ° C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Temperature in Children Undergoing MRI
An increasing number of children undergo Magnetic Resonance Imaging (MRI). In MRI, radio waves and magnetism are used to form images of the body's interior, to diagnose and monitoring diseases in children. Many children are sedated to be able to collaborate with the MRI procedure. Sedation and general anesthesia cause the child to some extent to lose the ability to regulate his or her own bodytemperature. MRI rooms are most often cold due to the function of the magnet, leading to a risk of hypothermia in young children. Conversely, the MRI scanner generates radio frequencies that are absorbed by the body and converted to heat, which especially in small children due to their large surface area can potentially result in an increase in bodytemperature. In this study we therefore want to investigate changes in bodytemperature in children who are undergoing MRI- scanning within the Neuroanesthesiology Clinic. Furthermore, we want to define possible risk factors for possible temperature changes. Our hypothesis: Children undergoing MRI scanning increase in bodytemperature.
Read the detailed description
Ear temperature is measured as we are primarily interested in describing temperature changes in the individual child and because this method is less invasive than the alternatives.
- Being tested
- Braun thermoscan /, IRT 6520
- Keywords
- magnetic resonance Imaging, paediatrics, temperature
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braun thermoscan /, IRT 6520Device
The temperature will be measured in both ears with an ear thermometer. Practically, we will measure the temperature twice when generel anaesthsia is established, and immidiately before and after the MRI scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta temperature ∆Tp = post-temperature - pre-temperature. Delta temperature is defined as the average temperature difference between pre-scan and post scan temperature measurement in right and left ear canal of the child before and after MRI scan.
The average of the temperature measured in the two ear canals is used if the difference is less than 0.5 degrees. If the temperature difference between the two ear canals exceeds 0.5 degrees, it is assumed that the lowest temperature is an error measurement e.g. due to physical block of the ear canal. In that case, the highest temperature measured in one of the two ear canals is used.
Measured: Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.
Secondary outcomes (6)
Childrens body surface area and temperature increase during MRI
Influence on body surface area calculated by weight in kilograms, height in centimeters. For calculation the Du Bois formula is used.
Measured: 20 minutes - 3 hours
Confounders influence on intervention and temperature outcome
Age ( years), height (centimeters ) BMI (kg/m^2) < 18.5 underweight, 18.5 -25 normal weight, > 25 overweight.
Measured: 20 minutes
MRI
Influence of MRI protocol: cerebrum, neuro axis, abdominal, heart and others. MRI duration (minutes) and MRI type (Tesla 1,5 or 3,0)
Measured: 20 minutes to 3 hours
Influence on body temperature
Underlying diseases, infection, fever and use contrast.
, use of contrast.
Measured: 5 minutes
Medication
Use of paracetamol (acetaminophen) same day of MRI-scanning
Measured: 5 minutes
External use of cover during MRI
Use of blankets to prevent heat loss in babies and children undergoing MRI-scan.
Measured: 20 minutes - 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start2 Mar 2020
- Primary completion14 Jun 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Field ExposureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thurid Waagstein Madsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thurid W Madsen, RN, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317378
- Sponsor's protocol ID
- TWMADSEN
- Acronym
- HOT-MR
- Status last verified
- Nov 2020
- First submitted
- 9 Mar 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Temperature in Children Undergoing MRI
- ClinicalTrials.gov ID
- NCT04317378
- Acronym / sponsor ID
- HOT-MR / TWMADSEN
- Keywords
- magnetic resonance Imaging, paediatrics, temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 23 Mar 2020 (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.
An increasing number of children undergo Magnetic Resonance Imaging (MRI). In MRI, radio waves and magnetism are used to form images of the body's interior, to diagnose and monitoring diseases in children. Many children are sedated to be able to collaborate with the MRI procedure. Sedation and general anesthesia cause the child to some extent to lose the ability to regulate his or her own bodytemperature. MRI rooms are most often cold due to the function of the magnet, leading to a risk of hypothermia in young children. Conversely, the MRI scanner generates radio frequencies that are absorbed by the body and converted to heat, which especially in small children due to their large surface area can potentially result in an increase in bodytemperature. In this study we therefore want to investigate changes in bodytemperature in children who are undergoing MRI- scanning within the Neuroanesthesiology Clinic. Furthermore, we want to define possible risk factors for possible temperature changes. Our hypothesis: Children undergoing MRI scanning increase in bodytemperature.
Detailed description
Ear temperature is measured as we are primarily interested in describing temperature changes in the individual child and because this method is less invasive than the alternatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 weeks to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 12 weeks to 12 years of age undergoing MRI procedure with the assistance of anesthesiologists from the Neuroanesthesiology Clinic may be included. Oral and written consent from the parent or relatives of the child will be obtained in accordance with science ethical rules.
Key inclusion criteria (3 listed)
- Age from 12 weeks to 12 years
- Children undergoing MRI scans with the help of anesthesia staff from the Neuroanesthesiology Clinic under general anesthesia or awake
- The children are recruited via prescriptions or the anesthetist immediately before scanning and outside the MRI room. All children who meet the criteria for MRI scan can be included. Acute MRI children, children admitted to intensive care and children who came is directly from the operation if consent is obtained.
Key exclusion criteria (4 listed)
- Inability at present. and relatives to speak and understand Danish or English. An authorized interpreter may be used for a family that does not have a Danish background and only if written and oral information material is understood otherwise the patient is excluded
- No consent to the study
- Anatomically not possible to measure ear temperature
- Temperature above 39 ° C
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 |
|---|---|---|
| Braun thermoscan /, IRT 6520The temperature will be measured in both ears with an ear thermometer. Practically, we will measure the temperature twice when generel anaesthsia is established, and immidiately before and after the MRI scan. | Device | – |
Primary outcome
Delta temperature ∆Tp = post-temperature - pre-temperature. Delta temperature is defined as the average temperature difference between pre-scan and post scan temperature measurement in right and left ear canal of the child before and after MRI scan.
Time frame: Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.
The average of the temperature measured in the two ear canals is used if the difference is less than 0.5 degrees. If the temperature difference between the two ear canals exceeds 0.5 degrees, it is assumed that the lowest temperature is an error measurement e.g. due to physical block of the ear canal. In that case, the highest temperature measured in one of the two ear canals is used.
6 secondary outcomes
Childrens body surface area and temperature increase during MRI
Time frame: 20 minutes - 3 hours
Confounders influence on intervention and temperature outcome
Time frame: 20 minutes
MRI
Time frame: 20 minutes to 3 hours
Influence on body temperature
Time frame: 5 minutes
Medication
Time frame: 5 minutes
External use of cover during MRI
Time frame: 20 minutes - 3 hours
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 5 Nov 2020.
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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.
Thurid W Madsen, RN study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Field Exposure and Temperature Change, Body, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 4 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 5 Nov 2020. 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 Denmark. 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?
Delta temperature ∆Tp = post-temperature - pre-temperature. Delta temperature is defined as the average temperature difference between pre-scan and post scan temperature measurement in right and left ear canal of the child before and after MRI scan. (time frame: Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.). 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 5 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.