Increase in Temperature in Children Undergoing MRI

Children, Only Clinical Trial

— HOT-MR  

Official title:

Changes in Temperature in Children Undergoing MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317378
• Other study ID #: TWMADSEN
• Status: Completed
• Start date: March 2, 2020
• Est. completion date: August 28, 2020

Study information

• Verified date: November 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 28, 2020
• Est. primary completion date: June 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Weeks to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Children, Only
• Magnetic Field Exposure
• Temperature Change, Body

Intervention

Device:
• Braun thermoscan /, IRT 6520
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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Blegdamsvej 9	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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