Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Soft tissue diameter
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 0 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Bone tissue diameter(Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once)
Investigators
Peter Paal, PD MD MBA EDAIC EDIC
MD PD MBA EDAIC EDIC
Medical University Innsbruck