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

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082066
• Other study ID #: AN2015-0093 348/4.17
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: February 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Infection
• Emergencies
• Infusion Site Injury

Intervention

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

Locations

Country	Name	City	State
Austria	University Hospital Innsbruck	Innsbruck

Sponsors (5)

Lead Sponsor	Collaborator
Medical University Innsbruck	Glodny Bernhard, MD PD Assoc. Prof., Laura Trefzer, Cand med, Ruth Kröss, MD EDAIC, Sabrina Neururer, DI BSc

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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