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

Completed

• Conditions: Infusion Site Injury; Bone Infection; Emergencies
• Interventions: Other: CT or MRI scan

• Registration Number: NCT03082066
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-11
• Study Start: 2017-03-15
• Study First Posted: 2017-03-17
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-27
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children	CT or MRI scan	Younger 18 years: Newborns, infants, small child, school child, teens
Adults	CT or MRI scan	Even or older 18 years

Primary Outcome Measures

Name	Time	Method
Soft tissue diameter	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 Outcome Measures

Name	Time	Method
Bone tissue diameter	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

Trial Locations

Locations (1)

University Hospital Innsbruck; 🇦🇹 Innsbruck, Austria