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

NCT03082066 | Completed

• 1 other identifier: AN2015-0093 348/4.17
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies; Infusion Site Injury; Bone Infection

Keywords

bone access; intraosseus needle; resuscitation; infusion; volume therapy; emergency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bone tissue diameter

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

Study Arms (2)

Children

Younger 18 years: Newborns, infants, small child, school child, teens

Other: CT or MRI scan

Adults

Even or older 18 years

Other: CT or MRI scan

Interventions

CT or MRI scan OTHER

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

Adults; Children

Eligibility Criteria

• Age: 0 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Innsbruck

Innsbruck, 5020, Austria

Location

MeSH Terms

Conditions

Emergencies

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PD MBA EDAIC EDIC

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 17, 2017
• Study Start: March 15, 2017
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)