Major Trauma PatientsNCT01058967
Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims
An observational study of Major Trauma Patients, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Trauma Patients
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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)
Who may be able to join
- Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance)
Who cannot join
- transfer from outside hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Medical Center
Houston, Texas, 77030
About this study
Official title: UTHSC-H Proposal for Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims.
The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers.
Read the 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.
- Conditions
- Major Trauma Patients
- Keywords
- Code III trauma (highest acuity), Life Flight aeromedical ambulance service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| major trauma victims | Code 3 patients (highest acuity) admitted to hospital via air ambulance service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Trauma PatientsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- SonoSite, Inc.
- Responsible party
- Principal investigator, Sara K Miller, The University of Texas Health Science Center, Houston
- Investigators
- Greg Press, MD, Principal investigator, UTHSC-Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058967
- Sponsor's protocol ID
- HSC-MS-08-0085
- Status last verified
- Apr 2019
- First submitted
- 27 Jan 2010
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25281177
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTHSC-H Proposal for Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims.
- ClinicalTrials.gov ID
- NCT01058967
- Acronym / sponsor ID
- HSC-MS-08-0085
- Conditions
- Major Trauma Patients
- Keywords
- Code III trauma (highest acuity), Life Flight aeromedical ambulance service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- SonoSite, Inc.
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jan 2010 (estimated)
- 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| major trauma victims | – | –Code 3 patients (highest acuity) admitted to hospital via air ambulance service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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)
Key inclusion criteria (1 listed)
- Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance)
Key exclusion criteria (1 listed)
- transfer from outside hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 6 month
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 18 Apr 2019.
- Derived from this study: PubMed 25281177Press 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.
Related trials for Major Trauma Patients
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
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.
Greg Press, MD principal investigator
UTHSC-Houston
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 Major Trauma Patients, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 18 Apr 2019. 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 United States. 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?
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. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058967, which also lists 1 linked publication.
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 18 Apr 2019.