Soft Tissue and Bone Diameter in Children and Adults for... | NCT03082066

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

NCT03082066

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Mar 2, 2021Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Emergencies
Infusion Site Injury
Bone Infection

Interventions

CT or MRI scan

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2017Actual

Primary Completion Date

Mar 20, 2018Actual

Completion Date

Mar 20, 2018Actual

First Submitted Date

Feb 27, 2017

First Submission Date that Met QC Criteria

Mar 11, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2021

Last Update Posted Date

Mar 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Paal, PD MD MBA EDAIC EDIC, MD PD MBA EDAIC EDIC, Medical University InnsbruckPrincipal Investigator

Lead Sponsor

Medical University InnsbruckOTHER

Collaborators

Name	Class
Ruth Kröss, MD EDAIC	UNKNOWN
Glodny Bernhard, MD PD Assoc. Prof.	UNKNOWN
Laura Trefzer, Cand med	UNKNOWN
Sabrina Neururer, DI BSc

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Innsbruck		Innsbruck		5020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided