An observational study in Magnetic Field Exposure, Temperature Change, Body and Children, Only, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 12 Weeks to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
93 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 74 is below the median of 99 across 25 observational studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.
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.
Time frame: 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.
Time frame: 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)
Time frame: 20 minutes to 3 hours
Influence on body temperature
Underlying diseases, infection, fever and use contrast. , use of contrast.
Time frame: 5 minutes
Medication
Use of paracetamol (acetaminophen) same day of MRI-scanning
Time frame: 5 minutes
External use of cover during MRI
Use of blankets to prevent heat loss in babies and children undergoing MRI-scan.
Time frame: 20 minutes - 3 hours
Anesthesia type and influence on body temperature
Generel anesthesia using propofol infusion or sevoflurane. Sedation or awake during MRI. ASA group 1-4
Time frame: 20 minutes - 3 hours.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark