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UltrasonographyNCT01074112

Keller Prehospital Ultrasound Study

An observational study of Ultrasonography and Multiple Trauma, run by Keller Fire Rescue at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is based on the premise that ultrasound is not commonly used in an ambulance. There are some departments that do deploy it into the field, but of those departments there is almost no data collected about its use. Read more about this study

Who is it for?
Any age
Conditions the study is for
Ultrasonography, Multiple Trauma, Kidney Calculi
What is being tested?
EFAST exam, Pelvic Ultrasound and Ultrasound Guided Vascular Access
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2010to not given
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: Residents and visitors of Keller,TX and the cities that Keller Fire Rescue provides mutual aide services to

Who may be able to join

  • Activation of the Keller Fire Rescue Emergency Medical Service
  • Meets disease process criteria described earlier

Who cannot join

  • Does not meet the disease process criteria

Trial locations and contacts

1 site in 1 country.

Jason P Bowman, EMT-P contact

817-992-1410

jbowman@cityofkeller.com

United States1 site
  • Keller Fire Rescue

    Keller, Texas, 76248

    Jason P Bowman, EMT-P, 817-992-1410, jbowman@cityofkeller.com

    Jason P Bowman, CCEMT-P

Other trials in United States

About this study

Official title: Keller Fire Rescue Study of Prehospital Ultrasound Use

The study is based on the premise that ultrasound is not commonly used in an ambulance. There are some departments that do deploy it into the field, but of those departments there is almost no data collected about its use. Currently Paramedics are not recognized by insurance companies as health care providers capable of performing ultrasound. If there were more data on the subject that may eventually change. We are hoping to prove that not only is ultrasound useful in an ambulance, but that paramedics are good at interpreting the results. We will save images, the paramedic's diagnosis and some basic information about the call. We will not save any protected health information (PHI) or any information linking the subject to the study. The data collected will be sent to a non-biased ultrasound reviewer to grade the images for the accuracy of diagnosis and the quality of the view obtained. This data will be used to formulate a report and statistics on paramedic's ability to perform ultrasound in the field.

Read the detailed description

In the last 30 years ultrasound has contributed greatly to many fields of medicine, emergency medicine has been no exception. In fact emergency medicine is currently one of the fastest growing uses of ultrasound technology. Just as the 12 lead machine was becoming widely popular in many ER's 25 years ago and found its way into the prehospital environment. There were many doubts as to the ability to train paramedics to read 12 leads and the necessity of the prehospital 12 lead. However a recent study showed paramedics to be on par with physicians in their ability to interpret STEMI's. And many paramedics now could not fathom a system without 12 leads. If a paramedic can be trained to interpret something as complex as a 12 lead, then it should be possible to train a paramedic to interpret an ultrasound. With the advances in ultrasound technology creating lighter, smaller, cheaper, and more durable machines, there is no reason not to put this valuable technology into the prehospital field. With its expanded role in the prehospital field, the 12 lead has moved from being a convenience to becoming a real tool with the ability to activate an emergency heart cath team from the field and bypass the ER saving precious minutes in door to balloon times. The ultrasound could soon do the same by alerting the surgical team of positive internal bleeding, ruptured ectopic pregnancy, or operable AAA and bypass the ER to go straight to surgery. This intervention could be life saving in the presence of these injuries. And to add to its usefulness, ultrasound can also help to gain intravenous access, determine endotracheal tube placement, detect pacemaker capture and determine a myriad of other less acute disease processes.

PURPOSE:

  1. To determine the utility of ultrasound in the prehospital emergency environment of a suburban city.
  2. To determine the ability to teach dual role firefighter paramedics multiple uses of ultrasound in the prehospital environment.
  3. To determine the ability of dual role firefighter paramedics to accurately and rapidly perform ultrasounds in the field

HYPOTHESIS:

  • The use of ultrasound in the field by dual role firefighter paramedics is poorly studied
  • The use of ultrasound in a suburban environment is poorly studied
  • Ultrasound will be performed on a clinically significant patient population
  • A wide array of ultrasound procedures can be taught quickly and reliably performed by field paramedics with no prior ultrasound experience
  • The use of ultrasound in the field will play a significant role in guiding the field presentation of a patient
  • Just as the 12 lead did before it, bringing ultrasound into the field will lead to significantly better patient care

DETAILS:

  • The study will be carried out in a city with a population of approx. 35000 with a non trauma hospital 15 minutes away and the trauma center 30 minutes away.
  • The main priority of this study is that it will not interfere with patient care
  • The study will be conducted at Keller Fire Station 4, C shift by Medic 584

PROCESS:

  • The procedures will be taught on shift and then tested in a skills lab
  • The ultrasound exam is performed by paramedics after patient has been placed in the ambulance.
  • Paramedics will record still images of ultrasound views for future review by approved EM ultrasound reviewers. The paramedics read of the ultrasound results will be recorded. If the paramedic feels the ultrasound shows a positive result they will report this in their run report.
  • The time it takes for the ultrasound to be performed will be recorded and any difficulty performing the exam will be noted.
  • Any hospital diverts that occur, as a result of the ultrasound will be recorded.
  • Electronic images will be saved for each scan, and an interpretation log sheet will be filled out. Scans will be over-read in a blinded fashion by a certified emergency medical ultrasound physician. Studies will be scored on technical adequacy as well as image quality.
  • The interpretations of the ultrasound director will be compared to those of the EMS providers, and the proportion of adequate studies will be assessed.
  • Performance on both a pre and post written and image-based test will be assessed before and after training.

PROTOCOLS:

PRIMARY EXAMS

  • We will perform E-FAST exams on all trauma patients with any possible injury to the abdomen or thorax, mechanism indicating a need for the exam, or at the paramedic's discretion
  • We will perform pregnancy exam on all female abdominal pain patients of child bearing age
  • We will perform ultrasound guided venous access on patients whom IV access is difficult but the patient's condition requires IV access and does not indicate the need for IO, this procedure will be done at the paramedics discretion.
  • We will perform AAA exam on all patients with a possible diagnosis of AAA. Measurements will be taken and compared to hospital measurements if available.
  • We will perform cardiac echo on patients in cardiac arrest with possible PEA if it does not detract from patient care.

SECONDARY EXAMS

  • We will perform renal ultrasound on all patients with flank pain to check for hydronephrosis. Positive findings will be documented.
  • We will check for pleural effusion in patients with decreased SpO2 of unknown etiology, especially if known renal or hepatic disease
  • We will determine ETT placement via ultrasound on every intubation if possible
  • We will check for mechanical capture in transcutaneous cardiac pacing
Being tested
EFAST exam, Pelvic Ultrasound, Ultrasound Guided Vascular Access, Focused Ultrasound Scan, Cardiac Ultrasound
Keywords
Ultrasound, Prehospital, Trauma, EMS, Paramedics, Sonography, Ultrasonography, Ambulance, FAST, EFAST
Medical subject headings
Multiple Trauma, Kidney Calculi, Aortic Aneurysm, Abdominal, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EFAST examDevice

    Also called FAST, Focused assessment with sonography for trauma

    Ultrasound of the heart, morisons pouch, pelvis, spleen and both lungs

  • Pelvic UltrasoundDevice

    Ultrasound view of the pelvis. including the bladder and uterus

  • Ultrasound Guided Vascular AccessProcedure or surgery

    Use of the ultrasound machine to identify a usable vein and guide the needle into the vein. After cannulation ultrasound is used to determine correct placement and identify extravasation.

  • Focused Ultrasound ScanDevice

    Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.

  • Cardiac UltrasoundDevice

    Also called Echocardiography, echocardiogram

    Ultrasound views of the heart

Study groups in NCT01074112
Study groupRoleWhat they receive
Abdominal TraumaPatients with mechanism of injury that could produce abdominal bleeding
Receives: Device: EFAST exam; Device: Cardiac Ultrasound
Female Abdominal PainFemale patients of child bearing age complaining of abdominal pain
Receives: Device: Pelvic Ultrasound
Difficult Vascular AccessPatients whom vascular access is needed but difficult
Receives: Procedure: Ultrasound Guided Vascular Access
Abdominal Aortic AnuerysmPatients who complain of or are suspected of having an abdominal aortic aneurysm
Receives: Device: Focused Ultrasound Scan
Pulseless Electrical ActivityPatients whom are in cardiac arrest and no pulse can be determined yet they show an electrical rhythm on the monitor
Receives: Device: Cardiac Ultrasound
Kidney Stones (Hydronephrosis)Patients who complain of flank pain
Receives: Device: Focused Ultrasound Scan
Plueral EffusionPatients with a history of renal or hepatic problems and complain of difficulty breathing of an unknown etiology
ETT placementfield intubated patients who need another means of verifying tube placement
Receives: Device: Focused Ultrasound Scan
Transcutaneous PacingPatients who are being externally paced and need a method of determining mechanical capture
Receives: Device: Cardiac Ultrasound
Paramedic DiscretionPatients in whom the paramedic feels that an ultrasound study would provide useful data in their treatment
Receives: Device: Focused Ultrasound Scan; Device: Cardiac Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Paramedic's ability to read an ultrasound will be determined

    Electronic images will be saved for each scan, and an interpretation log sheet will be filled out. Scans will be over-read in a blinded fashion by a certified emergency medical ultrasound physician. Studies will be scored on technical adequacy as well as image quality.

    Measured: After all study data has been collected

Secondary outcomes (1)
  1. The frequency of ultrasound use in the prehospital environment will be determined

    The number and types of usage as well as basic call data will be recorded. By determining the call type and the field diagnosis we can determine not only the number of uses but whether they positively affected the clinical outcome whether in the hospital or prehospital environment.

    Measured: After all study data has been collected

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2010 (estimated)
  2. Study startMar 2010

Resources

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
Cross-sectional
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074112
Sponsor's protocol ID
KFR-US-01
Status last verified
Feb 2010
First submitted
22 Feb 2010
Last updated
24 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ultrasonography and Multiple Trauma, run by Keller Fire Rescue 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 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2010. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jason P Bowman, EMT-P (817-992-1410, jbowman@cityofkeller.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Paramedic's ability to read an ultrasound will be determined (time frame: After all study data has been collected). 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 24 Feb 2010; AzTrials last refreshed its copy on 1 Nov 2026.

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