Keller Prehospital Ultrasound Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Keller Fire Rescue.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Keller Fire Rescue
ClinicalTrials.gov Identifier:
NCT01074112
First received: February 22, 2010
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Ultrasonography
Multiple Trauma
Kidney Calculi
Aortic Aneurysm, Abdominal
Pregnancy
Catheterization, Venous
Device: EFAST exam
Device: Pelvic Ultrasound
Procedure: Ultrasound Guided Vascular Access
Device: Focused Ultrasound Scan
Device: Cardiac Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Keller Fire Rescue Study of Prehospital Ultrasound Use

Resource links provided by NLM:


Further study details as provided by Keller Fire Rescue:

Primary Outcome Measures:
  • The Paramedic's ability to read an ultrasound will be determined [ Time Frame: After all study data has been collected ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The frequency of ultrasound use in the prehospital environment will be determined [ Time Frame: After all study data has been collected ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: March 2010
Groups/Cohorts Assigned Interventions
Abdominal Trauma
Patients with mechanism of injury that could produce abdominal bleeding
Device: EFAST exam
Ultrasound of the heart, morisons pouch, pelvis, spleen and both lungs
Other Names:
  • FAST
  • Focused assessment with sonography for trauma
Device: Cardiac Ultrasound
Ultrasound views of the heart
Other Name: Echocardiography, echocardiogram
Female Abdominal Pain
Female patients of child bearing age complaining of abdominal pain
Device: Pelvic Ultrasound
Ultrasound view of the pelvis. including the bladder and uterus
Difficult Vascular Access
Patients whom vascular access is needed but difficult
Procedure: Ultrasound Guided Vascular Access
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.
Abdominal Aortic Anuerysm
Patients who complain of or are suspected of having an abdominal aortic aneurysm
Device: Focused Ultrasound Scan
Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.
Pulseless Electrical Activity
Patients whom are in cardiac arrest and no pulse can be determined yet they show an electrical rhythm on the monitor
Device: Cardiac Ultrasound
Ultrasound views of the heart
Other Name: Echocardiography, echocardiogram
Kidney Stones (Hydronephrosis)
Patients who complain of flank pain
Device: Focused Ultrasound Scan
Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.
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
Device: Focused Ultrasound Scan
Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.
Transcutaneous Pacing
Patients who are being externally paced and need a method of determining mechanical capture
Device: Cardiac Ultrasound
Ultrasound views of the heart
Other Name: Echocardiography, echocardiogram
Paramedic Discretion
Patients in whom the paramedic feels that an ultrasound study would provide useful data in their treatment
Device: Focused Ultrasound Scan
Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.
Device: Cardiac Ultrasound
Ultrasound views of the heart
Other Name: Echocardiography, echocardiogram

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Residents and visitors of Keller,TX and the cities that Keller Fire Rescue provides mutual aide services to

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not meet the disease process criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074112

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

Locations
United States, Texas
Keller Fire Rescue Not yet recruiting
Keller, Texas, United States, 76248
Contact: Jason P Bowman, EMT-P    817-992-1410    jbowman@cityofkeller.com   
Principal Investigator: Jason P Bowman, CCEMT-P         
Sponsors and Collaborators
Keller Fire Rescue
  More Information

Additional Information:
No publications provided

Responsible Party: Jason Bowman, FF/EMTP, Keller Fire Rescue
ClinicalTrials.gov Identifier: NCT01074112     History of Changes
Other Study ID Numbers: KFR-US-01
Study First Received: February 22, 2010
Last Updated: February 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Keller Fire Rescue:
Ultrasound
Prehospital
Trauma
EMS
Paramedics
Sonography
Ultrasonography
Ambulance
FAST
EFAST

Additional relevant MeSH terms:
Aortic Aneurysm
Multiple Trauma
Aortic Aneurysm, Abdominal
Kidney Calculi
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 01, 2014