Increase in Temperature in Children Undergoing MRI

NCT04317378 | Completed DMC

• 1 other identifier: TWMADSEN
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Field Exposure; Temperature Change, Body; Children, Only

Keywords

magnetic resonance Imaging; paediatrics; temperature

Outcome Measures

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.

  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 Outcomes (6)

• Childrens body surface area and temperature increase during MRI

  20 minutes - 3 hours

• Confounders influence on intervention and temperature outcome

  20 minutes

• MRI

  20 minutes to 3 hours

• Influence on body temperature

  5 minutes

• Medication

  5 minutes

Other Outcomes (1)

• Anesthesia type and influence on body temperature

  20 minutes - 3 hours.

Interventions

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.

Eligibility Criteria

• Age: 12 Weeks - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Blegdamsvej 9

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thurid W Madsen, RN

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse anesthetist, Cand scient san student

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 23, 2020
• Study Start: March 2, 2020
• Primary Completion: June 14, 2020
• Study Completion: August 28, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

DK (1)