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Clinical Trials/NCT06278376
NCT06278376
Completed
Not Applicable

Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans: a Retrospective, Longitudinal Study

Jessa Hospital1 site in 1 country410 target enrollmentApril 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Magnetic Resonance Imaging
Sponsor
Jessa Hospital
Enrollment
410
Locations
1
Primary Endpoint
Incidence
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.

Detailed Description

Magnetic resonance imaging (MRI) is a non-invasive imaging technique that allows physicians to visualize our anatomy, generating high-quality pictures of our body's internal structure at many different angles. The principle behind MRI, known as nuclear magnetic resonance (NMR), revolves around hydrogen atoms (or protons) that can be found everywhere in our entire body, such as in bones, blood, organs, skin, muscles and more. Protons have their own magnetic moment and angular momentum, allowing them to spin in a certain direction. By subjecting these spinning protons to a strong magnetic field they will be oriented along the axis of the magnetic field, either with or against the direction of the magnetic field. MRI machines generate this field using a large magnet surrounding the patient. Electric gradient coils allow the strength of the field to be adjustable, usually around 0,5 or 1,5 tesla. MRI has many advantages compared to other imaging techniques, i.e. CT (computed tomography), including the lack of radiation, the ability to show abnormalities of soft tissues, the ability to visualize blood flow, and contrasting agents that are less likely to cause adverse effects like allergic reactions. There are also some disadvantages or limitations, however: implants or metallic objects inside the body can make images unclear at best or harm the patient at worst; similarly, movements made by the patient can make images unclear as well. Lastly, MRI is a more expensive and slower technique compared to other imaging techniques. Children undergoing an MRI are often sedated before being placed inside the machine. After the scan is over, the children will be brought to a recovery area, where they can slowly recover from the sedation until they are fully awake again. Some common side effects resulting from the sedation may be vomiting, drowsiness and/or dizziness. The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.

Registry
clinicaltrials.gov
Start Date
April 25, 2023
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jessa Hospital
Responsible Party
Principal Investigator
Principal Investigator

Stessel Björn

Professor Anesthesiology, MD, PhD

Jessa Hospital

Eligibility Criteria

Inclusion Criteria

  • Children undergoing an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February
  • Age between 6 months and 16 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence

Time Frame: Between 2016 and 2023

Incidence of diagnostic MRI in childeren

Secondary Outcomes

  • Clinical indications(Between 2016 and 2023)
  • Clinical outcome: mortality(Between 2016 and 2023)
  • Therapeutical implications: treatment(Between 2016 and 2023)
  • Evaluation of body part(Between 2016 and 2023)
  • Influence of COVID-19 pandemic(Between 2016 and 2023)
  • Clinical outcome: admission to hospital(Between 2016 and 2023)
  • Therapeutical implications: diagnosis(Between 2016 and 2023)
  • Evaluation of age(Between 2016 and 2023)
  • Evaluation of symptoms(Between 2016 and 2023)
  • Clinical outcome: adverse event(Between 2016 and 2023)
  • Clinical outcome: surgery(Between 2016 and 2023)

Study Sites (1)

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