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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Bone Infection; Infusion Site Injury
• Intervention / Treatment: Other: CT or MRI scan

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 5020
    • University Hospital Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children; Younger 18 years: Newborns, infants, small child, school child, teens	Other: CT or MRI scan; CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter
Adults; Even or older 18 years	Other: CT or MRI scan; CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue diameter	CT or MRI performed for underlying disease. Diameter of soft tissue at the site of recommended intraosseus bone access	Retrospective single time measurement on MRI or CT scan. Measurement will last approx. 10 minutes, an will happen only once

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone tissue diameter	CT or MRI performed for underlying disease. Diameter of bone cortical and spongiosa at the site of recommended intraosseus bone access	Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: Ruth Kröss, MD EDAIC; Glodny Bernhard, MD PD Assoc. Prof.; Laura Trefzer, Cand med; Sabrina Neururer, DI BSc

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 11, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: emergency; infusion; resuscitation; bone access; intraosseus needle; volume therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: AN2015-0093 348/4.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No