Cardiac Arrest Due to Trauma (Disorder)NCT03491787
Ultrasound-guidance for Intraosseous Access During Earthquake
An observational study of Cardiac Arrest Due to Trauma (Disorder), run by San Salvatore Hospital of L'Aquila.
Trial summary
The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest Due to Trauma (Disorder)
- What is being tested?
- Ultrasound guidance
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2016to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People under the rubble, after the earthquake
Who may be able to join
- traumatic cardiac arrest
Who cannot join
- non traumatic cardiac arrest
- beheading
- post-mortem hypostasis
- carbonized bodies
- dismembered bodies
About this study
Official title: Ultrasound-guidance for Intraosseous Access Could Provide Benefits for Resuscitation in Out-of-hospital Traumatic Cardiac Arrest: a Field Report During Earthquake on Amatrice (Italy), August 24, 2016
The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest
Read the detailed description
The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, decreasing the time for drug administration and providing some benefits during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest.
- Conditions
- Cardiac Arrest Due to Trauma (Disorder)
- Being tested
- Ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceDevice
The ultrasound guidance was used to obtain intraosseous access
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guidance | The ultrasound guidance was used to establish intraosseous access Receives: Device: Ultrasound guidance | |
| Not ultrasound guidance | The ultrasound guidance was not used to obtain intraosseous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraosseus access
The time used to esteblish the intraosseus access
Measured: up to 10 minutes
Secondary outcomes (1)
Return of spontaneous circulation
The time to obtain the return of spontaneous circulation
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start26 Sep 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest Due to Trauma (Disorder)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491787
- Sponsor's protocol ID
- 05/01/2017, n.12
- Status last verified
- May 2025
- First submitted
- 28 Mar 2018
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guidance for Intraosseous Access Could Provide Benefits for Resuscitation in Out-of-hospital Traumatic Cardiac Arrest: a Field Report During Earthquake on Amatrice (Italy), August 24, 2016
- ClinicalTrials.gov ID
- NCT03491787
- Acronym / sponsor ID
- 05/01/2017, n.12
- Conditions
- Cardiac Arrest Due to Trauma (Disorder)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 2018 (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.
The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest
Detailed description
The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, decreasing the time for drug administration and providing some benefits during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guidance | – | Device: Ultrasound guidanceThe ultrasound guidance was used to establish intraosseous access |
| Not ultrasound guidance | – | –The ultrasound guidance was not used to obtain intraosseous access |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People under the rubble, after the earthquake
Key inclusion criteria (1 listed)
- traumatic cardiac arrest
Key exclusion criteria (5 listed)
- non traumatic cardiac arrest
- beheading
- post-mortem hypostasis
- carbonized bodies
- dismembered bodies
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 |
|---|---|---|
| Ultrasound guidanceThe ultrasound guidance was used to obtain intraosseous access | Device | Ultrasound guidance |
Primary outcome
Intraosseus access
Time frame: up to 10 minutes
The time used to esteblish the intraosseus access
1 secondary outcome
Return of spontaneous circulation
Time frame: up to 1 hour
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 16 May 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest Due to Trauma (Disorder), run by San Salvatore Hospital of L'Aquila.
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 5 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraosseus access (time frame: up to 10 minutes). 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 16 May 2025.