Clinical trial NCT03082066: Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access
Official title: Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Infusion Site Injury
Bone Infection
Keywords: bone access
intraosseus needle
resuscitation
infusion
volume therapy
emergency
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Ruth Kröss, MD EDAIC
name: Glodny Bernhard, MD PD Assoc. Prof.
name: Laura Trefzer, Cand med
name: Sabrina Neururer, DI BSc
First posted: 2017-03-17
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Soft tissue diameter
timeFrame: Retrospective single time measurement on MRI or CT scan. Measurement will last approx. 10 minutes, an will happen only once
Secondary outcomes:
measure: Bone tissue diameter
timeFrame: Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
Study officials:
References: