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NCT Number: NCT03082066

Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access

Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites.

Primary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this retrospective study.

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Key information

Conditions

Emergencies Bone Infection Disease Attributes Infusion Site Injury Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Innsbruck

Innsbruck, 5020, Austria

About this study

Retrospective observational single centre study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites. Data is gathered from patients who undergo either MRI or CT scanning for any disease and where bone at the IO puncture site is accessible for measurements required for this study.

Primary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 0-90 years of age with elective or emergency MRI or CT scan within a 24 months period at the university hospital Innsbruck, Austria. Patients in analgosedation, anaesthesia, and stand-by

Exclusion criteria

  • Pathologies at recommended intraosseus puncture - and investigation- site, i.e. proximal humerus, distal femur, proximal and distal tibia

Treatment and study plan

CT or MRI scan

Other

CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter

Primary outcomes

  1. Soft tissue diameter

    Time frame: Retrospective single time measurement on MRI or CT scan. Measurement will last approx. 10 minutes, an will happen only once

    CT or MRI performed for underlying disease. Diameter of soft tissue at the site of recommended intraosseus bone access

Secondary outcomes

  1. Bone tissue diameter

    Time frame: Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once

    CT or MRI performed for underlying disease. Diameter of bone cortical and spongiosa at the site of recommended intraosseus bone access

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • Glodny Bernhard, MD PD Assoc. Prof.
  • Laura Trefzer, Cand med
  • Ruth Kröss, MD EDAIC
  • Sabrina Neururer, DI BSc

Registry information

Official study title

Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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