Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04333680
Other study ID # H-46446
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 27, 2021
Est. completion date June 3, 2021

Study information

Verified date March 2022
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound exam performed on blunt and penetrating trauma patients who are too critically injured to be transported to a CT scanner. Low-frequency ultrasound is used to image the abdomen and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Whether the use of one transducer or the other is better for this application is not well studied. In this study, physician ultrasound operators will perform the FAST exam on healthy non-injured volunteers to determine if the speed or quality of images between the two transducer types is different.


Description:

The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound exam performed on blunt and penetrating trauma patients who are too critically injured to be transported to a CT scanner. In performing this exam, time to acquisition of adequate images is crucial to clinical decision-making as patients undergoing this exam have a high probability of deteriorating if not intervened on appropriately. Low-frequency ultrasound is used to image the abdominal cavity and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Both of these transducers are capable of acquiring the images necessary to interpret a FAST exam, but it has not been well studied whether using one transducer instead of the other improves time to image acquisition or image quality. In this study, physician ultrasound operators are asked to perform FAST exams on healthy non-injured volunteers for the purpose of determining if there is a difference in the time to acquisition or quality of images between phased-array and curvilinear transducers.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date June 3, 2021
Est. primary completion date June 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: Study's ultrasound operators must be emergency medicine residents or PA/NP fellows currently enrolled in an emergency medicine training program between the ages of 18 - 64 years who are not pregnant. Study's healthy normal volunteers must be emergency medicine faculty, fellows, or PA/NPs aged 18-64 with no anatomic abnormalities, prior surgeries, or significant chronic medical conditions. Exclusion Criteria: Pregnant women Prisoners Anyone below the age of 18 or above the age of 64 years old Individuals with abnormal/thoracic anatomy (such as individuals with situs inversus) and individuals with chronic medical conditions that would limit their ability to participate in the study or have ultrasound images taken of them.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Focused Assessment of Sonography for Trauma Exam
Speed and image quality of ultrasound exams performed with either transducer specified in the arms.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time Required Total time necessary to perform a FAST ultrasound examination using either transducer specified, starting from when the exam is begun to when the last view is completed by the ultrasound operator. The average exam is estimated to take no more than 10 minutes to complete. Assessed and reported at study completion, estimated 1 year
Secondary Image Quality Quality of the images, based on retrospectively reviewing and assessing the interpretability of sonographic images taken during the FAST exam performed with either transducer. These images are captured during the performance of the ultrasound exam. Assessed and reported at study completion, estimated 1 year
See also
  Status Clinical Trial Phase
Completed NCT04567901 - GNRI and Influence of Nutrition on the Mortality of Trauma Patients
Enrolling by invitation NCT05794165 - Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism Phase 2
Not yet recruiting NCT06326827 - In'Oss™ (MBCP® Putty) Ortho
Recruiting NCT04403204 - ICG Fluorescence Imaging in Post-traumatic Infection
Completed NCT04913402 - Sufentanil Used by Paramedics to Treat Pain in Acute Trauma
Not yet recruiting NCT06070350 - Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children Phase 3
Recruiting NCT05616130 - Pathological Myeloid Activation After Sepsis and Trauma
Completed NCT05628519 - Captain Sonar Impact on Trauma Patient Management N/A
Recruiting NCT04907240 - Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Recruiting NCT06123104 - Assessment of Automatic Tourniquets for Soldiers During Wartime N/A
Recruiting NCT05865327 - UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture N/A
Completed NCT05175872 - Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit
Not yet recruiting NCT04387305 - Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study Phase 3
Recruiting NCT04416412 - ICG Fluorescence Imaging in Open Fracture Trauma Patients
Completed NCT04080479 - Bolus Versus Continuous Enteral Tube Feeding N/A
Completed NCT04030832 - Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
Active, not recruiting NCT06063434 - Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game N/A
Not yet recruiting NCT04954768 - Epidemiological Characteristics of Elderly Trauma Patients in Zhejiang Province and Development of Geriatric Trauma Short-term Mortality Prediction Model
Completed NCT04327895 - Surgery in Context of Terrorist Attack : a Survey of French Surgeons
Completed NCT03888703 - The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation N/A