Increase in Temperature in Children Undergoing MRI (HOT-MR)

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.

Study Overview

• Status: Completed
• Conditions: Children, Only; Temperature Change, Body; Magnetic Field Exposure
• Intervention / Treatment: Device: Braun thermoscan /, IRT 6520

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Blegdamsvej 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	20 minutes to 3 hours
Influence on body temperature	Underlying diseases, infection, fever and use contrast. , use of contrast.	5 minutes
Medication	Use of paracetamol (acetaminophen) same day of MRI-scanning	5 minutes
External use of cover during MRI	Use of blankets to prevent heat loss in babies and children undergoing MRI-scan.	20 minutes - 3 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia type and influence on body temperature	Generel anesthesia using propofol infusion or sevoflurane. Sedation or awake during MRI. ASA group 1-4	20 minutes - 3 hours.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Director: Thurid W Madsen, RN, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): June 14, 2020
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: temperature; paediatrics; magnetic resonance Imaging
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: TWMADSEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No