UltrasonographyNCT01074112
Keller Prehospital Ultrasound Study
An observational study of Ultrasonography and Multiple Trauma, run by Keller Fire Rescue at 1 site in United States.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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.
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
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:
- To determine the utility of ultrasound in the prehospital emergency environment of a suburban city.
- To determine the ability to teach dual role firefighter paramedics multiple uses of ultrasound in the prehospital environment.
- 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
- Conditions
- Ultrasonography, Multiple Trauma, Kidney Calculi, Aortic Aneurysm, Abdominal, Pregnancy, Catheterization, Venous
- 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 group | Role | What they receive |
|---|---|---|
| Abdominal Trauma | Patients with mechanism of injury that could produce abdominal bleeding Receives: Device: EFAST exam; Device: Cardiac Ultrasound | |
| Female Abdominal Pain | Female patients of child bearing age complaining of abdominal pain Receives: Device: Pelvic Ultrasound | |
| Difficult Vascular Access | Patients whom vascular access is needed but difficult Receives: Procedure: Ultrasound Guided Vascular Access | |
| Abdominal Aortic Anuerysm | Patients who complain of or are suspected of having an abdominal aortic aneurysm Receives: Device: Focused Ultrasound Scan | |
| Pulseless Electrical Activity | Patients 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 Effusion | Patients with a history of renal or hepatic problems and complain of difficulty breathing of an unknown etiology | |
| ETT placement | field intubated patients who need another means of verifying tube placement Receives: Device: Focused Ultrasound Scan | |
| Transcutaneous Pacing | Patients who are being externally paced and need a method of determining mechanical capture Receives: Device: Cardiac Ultrasound | |
| Paramedic Discretion | Patients 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.
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)
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.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keller Fire Rescue
- Sponsor type
- Other government
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keller Fire Rescue Study of Prehospital Ultrasound Use
- ClinicalTrials.gov ID
- NCT01074112
- Acronym / sponsor ID
- KFR-US-01
- Conditions
- Ultrasonography, Multiple Trauma, Kidney Calculi, Aortic Aneurysm, Abdominal, Pregnancy, Catheterization, Venous
- Keywords
- Ultrasound, Prehospital, Trauma, EMS, Paramedics, Sonography, Ultrasonography, Ambulance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Keller Fire RescueOther government
- Study start
- Mar 2010
- First posted
- 24 Feb 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 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.
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:
- To determine the utility of ultrasound in the prehospital emergency environment of a suburban city.
- To determine the ability to teach dual role firefighter paramedics multiple uses of ultrasound in the prehospital environment.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Abdominal Trauma | – | Device: EFAST exam, Device: Cardiac UltrasoundPatients with mechanism of injury that could produce abdominal bleeding |
| Female Abdominal Pain | – | Device: Pelvic UltrasoundFemale patients of child bearing age complaining of abdominal pain |
| Difficult Vascular Access | – | Procedure: Ultrasound Guided Vascular AccessPatients whom vascular access is needed but difficult |
| Abdominal Aortic Anuerysm | – | Device: Focused Ultrasound ScanPatients who complain of or are suspected of having an abdominal aortic aneurysm |
| Pulseless Electrical Activity | – | Device: Cardiac UltrasoundPatients whom are in cardiac arrest and no pulse can be determined yet they show an electrical rhythm on the monitor |
| Kidney Stones (Hydronephrosis) | – | Device: Focused Ultrasound ScanPatients who complain of flank pain |
| Plueral Effusion | – | –Patients with a history of renal or hepatic problems and complain of difficulty breathing of an unknown etiology |
| ETT placement | – | Device: Focused Ultrasound Scanfield intubated patients who need another means of verifying tube placement |
| Transcutaneous Pacing | – | Device: Cardiac UltrasoundPatients who are being externally paced and need a method of determining mechanical capture |
| Paramedic Discretion | – | Device: Focused Ultrasound Scan, Device: Cardiac UltrasoundPatients in whom the paramedic feels that an ultrasound study would provide useful data in their treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents and visitors of Keller,TX and the cities that Keller Fire Rescue provides mutual aide services to
Key inclusion criteria (2 listed)
- Activation of the Keller Fire Rescue Emergency Medical Service
- Meets disease process criteria described earlier
Key exclusion criteria (1 listed)
- Does not meet the disease process criteria
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 |
|---|---|---|
| EFAST examAlso: FAST, Focused assessment with sonography for traumaUltrasound of the heart, morisons pouch, pelvis, spleen and both lungs | Device | Abdominal Trauma |
| Pelvic UltrasoundUltrasound view of the pelvis. including the bladder and uterus | Device | Female Abdominal Pain |
| Ultrasound Guided Vascular AccessUse 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. | Procedure or surgery | Difficult Vascular Access |
| Focused Ultrasound ScanUse of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places. | Device | Abdominal Aortic Anuerysm, ETT placement, Kidney Stones (Hydronephrosis), Paramedic Discretion |
| Cardiac UltrasoundAlso: Echocardiography, echocardiogramUltrasound views of the heart | Device | Abdominal Trauma, Paramedic Discretion, Pulseless Electrical Activity, Transcutaneous Pacing |
Primary outcome
The Paramedic's ability to read an ultrasound will be determined
Time frame: After all study data has been collected
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.
1 secondary outcome
The frequency of ultrasound use in the prehospital environment will be determined
Time frame: After all study data has been collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
- Helpful website on prehospital ultrasoundLink provided by the sponsor.
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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.
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 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.