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Completed

NCT Number: NCT04317378

Increase 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.

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Key information

Conditions

Magnetic Field Exposure Body Temperature Changes Children, Only Pathological Conditions, Signs and Symptoms Signs and Symptoms Temperature Change, Body

Age range

12 week–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Blegdamsvej 9

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Braun thermoscan /, IRT 6520

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Childrens body surface area and temperature increase during MRI

    Time frame: 20 minutes - 3 hours

    Influence on body surface area calculated by weight in kilograms, height in centimeters. For calculation the Du Bois formula is used.

  2. Confounders influence on intervention and temperature outcome

    Time frame: 20 minutes

    Age ( years), height (centimeters ) BMI (kg/m^2) < 18.5 underweight, 18.5 -25 normal weight, > 25 overweight.

  3. MRI

    Time frame: 20 minutes to 3 hours

    Influence of MRI protocol: cerebrum, neuro axis, abdominal, heart and others. MRI duration (minutes) and MRI type (Tesla 1,5 or 3,0)

  4. Influence on body temperature

    Time frame: 5 minutes

    Underlying diseases, infection, fever and use contrast.

    , use of contrast.

  5. Medication

    Time frame: 5 minutes

    Use of paracetamol (acetaminophen) same day of MRI-scanning

  6. External use of cover during MRI

    Time frame: 20 minutes - 3 hours

    Use of blankets to prevent heat loss in babies and children undergoing MRI-scan.

Other outcomes

  1. Anesthesia type and influence on body temperature

    Time frame: 20 minutes - 3 hours.

    Generel anesthesia using propofol infusion or sevoflurane. Sedation or awake during MRI. ASA group 1-4

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Changes in Temperature in Children Undergoing MRI

Acronym: HOT-MR

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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