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Clinical Trials/NCT04317378
NCT04317378CompletedNot Applicable

Changes in Temperature in Children Undergoing MRI

Rigshospitalet, Denmark1 site in 1 country74 target enrollmentStarted: March 2, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
74
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Weeks to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • External use of cover during MRI(20 minutes - 3 hours)
  • MRI(20 minutes to 3 hours)
  • Confounders influence on intervention and temperature outcome(20 minutes)
  • Childrens body surface area and temperature increase during MRI(20 minutes - 3 hours)
  • Influence on body temperature(5 minutes)
  • Medication(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thurid Waagstein Madsen

Nurse anesthetist, Cand scient san student

Rigshospitalet, Denmark

Study Sites (1)

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