Ultrasound-guidance for Intraosseous Access During Earthq... | NCT03491787

Studies
Ultrasound-guidance for Intraosseous Access During Earthquake

NCT03491787

Sponsor

San Salvatore Hospital of L'Aquila

Status

Completed

Last Update Posted

May 16, 2025Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Cardiac Arrest Due to Trauma (Disorder)

Interventions

Ultrasound guidance

Countries

Not provided

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

May 2025

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

Sep 26, 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 28, 2018

First Submission Date that Met QC Criteria

Apr 6, 2018

First Posted Date

Apr 9, 2018Actual

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

May 15, 2025

Last Update Posted Date

May 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emiliano Petrucci, Medical Doctor of Anesthesia and Intensive Care Unit, San Salvatore Hospital of L'AquilaPrincipal Investigator

Lead Sponsor

San Salvatore Hospital of L'AquilaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound guidance		The ultrasound guidance was used to establish intraosseous access	Device: Ultrasound guidance
Not ultrasound guidance		The ultrasound guidance was not used to obtain intraosseous access

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound guidance	Device	The ultrasound guidance was used to obtain intraosseous access	Ultrasound guidance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraosseus access	The time used to esteblish the intraosseus access	up to 10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Return of spontaneous circulation	The time to obtain the return of spontaneous circulation	up to 1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

traumatic cardiac arrest

Exclusion Criteria:

non traumatic cardiac arrest
beheading
post-mortem hypostasis
carbonized bodies
dismembered bodies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

People under the rubble, after the earthquake

Sampling Method

Non-Probability Sample