Increase in Temperature in Children Undergoing MRI

NCT ID: NCT04317378

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2020-08-28

Brief Summary

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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

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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.

Conditions

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Magnetic Field Exposure Temperature Change, Body Children, Only

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Weeks

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thurid Waagstein Madsen

Nurse anesthetist, Cand scient san student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thurid W Madsen, RN

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Blegdamsvej 9

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TWMADSEN

Identifier Type: -

Identifier Source: org_study_id