Clinical trial NCT04317378: Increase in Temperature in Children Undergoing MRI
Official title: Changes in Temperature in Children Undergoing MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Field Exposure
Temperature Change, Body
Children, Only
Keywords: magnetic resonance Imaging
paediatrics
temperature
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Ear temperature scan within 5 minuts before and after MRI right outside the MRI suite.
Secondary outcomes:
measure: Childrens body surface area and temperature increase during MRI
timeFrame: 20 minutes - 3 hours
measure: Confounders influence on intervention and temperature outcome
timeFrame: 20 minutes
measure: MRI
timeFrame: 20 minutes to 3 hours
measure: Influence on body temperature
timeFrame: 5 minutes
measure: Medication
timeFrame: 5 minutes
measure: External use of cover during MRI
timeFrame: 20 minutes - 3 hours
Other outcomes:
measure: Anesthesia type and influence on body temperature
timeFrame: 20 minutes - 3 hours.
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Blegdamsvej 9
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thurid W Madsen, RN
role: STUDY_DIRECTOR
References: