EmergenciesNCT03082066
Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access
An observational study of Emergencies and Infusion Site Injury, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 0 to 90 years
- Conditions the study is for
- Emergencies, Infusion Site Injury, Bone Infection
- What is being tested?
- CT or MRI scan
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 15 Mar 2017to 20 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 90 years
- All sexes
- Child, Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Pathologies at recommended intraosseus puncture - and investigation- site, i.e. proximal humerus, distal femur, proximal and distal tibia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults
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.
Read the 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
- Conditions
- Emergencies, Infusion Site Injury, Bone Infection
- Being tested
- CT or MRI scan
- Keywords
- bone access, intraosseus needle, resuscitation, infusion, volume therapy, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT or MRI scanOther
CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter
| Study group | Role | What they receive |
|---|---|---|
| Children | Younger 18 years: Newborns, infants, small child, school child, teens Receives: Other: CT or MRI scan | |
| Adults | Even or older 18 years Receives: Other: CT or MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue diameter
CT or MRI performed for underlying disease. Diameter of soft tissue at the site of recommended intraosseus bone access
Measured: 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
CT or MRI performed for underlying disease. Diameter of bone cortical and spongiosa at the site of recommended intraosseus bone access
Measured: Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start15 Mar 2017
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Ruth Kröss, MD EDAIC, Glodny Bernhard, MD PD Assoc. Prof., Laura Trefzer, Cand med, Sabrina Neururer, DI BSc
- Responsible party
- Principal investigator, Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082066
- Sponsor's protocol ID
- AN2015-0093 348/4.17
- Status last verified
- Feb 2021
- First submitted
- 27 Feb 2017
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults
- ClinicalTrials.gov ID
- NCT03082066
- Acronym / sponsor ID
- AN2015-0093 348/4.17
- Conditions
- Emergencies, Infusion Site Injury, Bone Infection
- Keywords
- bone access, intraosseus needle, resuscitation, infusion, volume therapy, emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Ruth Kröss, MD EDAIC, Glodny Bernhard, MD PD Assoc. Prof., Laura Trefzer, Cand med, Sabrina Neururer, DI BSc
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: CT or MRI scanYounger 18 years: Newborns, infants, small child, school child, teens |
| Adults | – | Other: CT or MRI scanEven or older 18 years |
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Pathologies at recommended intraosseus puncture - and investigation- site, i.e. proximal humerus, distal femur, proximal and distal tibia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT or MRI scanCT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter | Other | Adults, Children |
Primary outcome
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
1 secondary outcome
Bone tissue diameter
Time frame: Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Infusion Site Injury, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.