Prospective Evaluation of Aeromedical EMS Ultrasound in M... | NCT01058967

Studies
Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims

NCT01058967

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Apr 18, 2019Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Major Trauma Patients

Interventions

Not provided

Countries

United States

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

Apr 2019

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

Jan 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Jan 27, 2010

First Posted Date

Jan 29, 2010Estimated

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

Apr 16, 2019

Last Update Posted Date

Apr 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sara K Miller, Assistant Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Name	Class
SonoSite, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers.

Detailed Description

This study will be divided into three parts. The first portion involves the education/inservices of the aeromedical prehospital providers to document the knowledge and skills necessary to perform and interpret eFAST exams using ultrasound pre hospitalization.

The second portion involves testing the logistics of utilization of prehospital ultrasound. Data will be collected by the participating aeromedical prehospital providers to rate the durability of the equipment, difficulty in preforming the eFAST exam, interference with other actions and ability of retention of images.

The third portion will involve the aeromedical prehospital providers performing the eFAST exam using the ultrasound prehospital and comparing their findings with the gold standard exam, CT scan, while patient is in the emergency department.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
major trauma victims		Code 3 patients (highest acuity) admitted to hospital via air ambulance service

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome for this study is to determine if the aeromedical prehospital providers are able to accurately and rapidly perform and interpret eFAST exams in major trauma victims.		6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance)

Exclusion Criteria:

transfer from outside hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have experienced a major traumatic injury highest acuity trauma activation (Code III status) transported from scene to hospital via Life Flight (hospital aeroambulance service)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greg Press, MD	UTHSC-Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Hermann Hospital - Medical Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25281177	Derived	Press GM, Miller SK, Hassan IA, Alade KH, Camp E, Junco DD, Holcomb JB. Prospective evaluation of prehospital trauma ultrasound during aeromedical transport. J Emerg Med. 2014 Dec;47(6):638-45. doi: 10.1016/j.jemermed.2014.07.056. Epub 2014 Oct 1.