Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04188899 |
| Other study ID # |
1910093637 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 28, 2019 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Arizona |
| Contact |
Srikar Adhikari, MD, MS |
| Phone |
520-621-3623 |
| Email |
sadhikari[@]aemrc.arizona.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Early identification of tissue injury from a rattlesnake bite is critical to prevent
complications and reduce health care costs. Given the limitations of clinical assessment,
there is a need to develop a more objective reproducible, anatomically detailed diagnostic
tool for to accurately assess tissue damage and assist with timely administration of
antivenom, if needed. Emergency physician performed point-of-care ultrasonography has been
shown to be beneficial in the diagnosis and management of skin and soft tissue infections.
The innovative use of bedside ultrasound technology can provide new information to
individualize antivenom treatment and to improve patient outcomes. The objectives of this
study is to compare clinical assessment and bedside ultrasound findings in the detection of
tissue injury in emergency department patients with rattle snakebite and determine if bedside
ultrasound can alter management (antivenom dosing) in emergency department patients with
rattle snakebite.
Description:
Arizona has the highest per capita rate of rattlesnake envenomation (the process by which
venom is injected by the bite of a venomous animal) in the United States leading to millions
of dollars in health care costs. Local tissue destruction typically manifests in the first
few hours after snakebite and can progress over days or weeks leading to long-term
complications such as muscle, nerve, and circulatory damage. The cornerstone in the treatment
of rattlesnake envenomation is accurate estimation of progression of local tissue damage and
timely administration of antivenom to halt the progression of venom effects. The initial
decision to administer antivenom is based on clinical parameters such as edema, induration,
bullae and blisters. The need for repeat doses of antivenom is determined by serial clinical
assessments and laboratory parameters. However, no definitive clinical or laboratory
parameters currently exist. The current practice is limited by inter-observer variability in
the clinical assessment and the inability to accurately assess the extent of tissue injury.
In a significant number of cases, it is difficult to accurately track the progression of the
venom effects until they become more pronounced and severe. With the limitations of clinical
assessment, administration of antivenom is delayed potentially resulting in poor patient
outcomes. A further complicating factor is that not all rattlesnake bites result in
envenomation. A substantial number of bites by rattlesnakes can result in "dry bite" in which
snake venom is not transferred from snake to human and thus will not cause tissue
destruction.4 Because of limitations of clinical assessments, these patients receive
antivenom even though it is not necessary. This liberal and inappropriate use of antivenom is
not cost effective and can also affect patient safety.
Early identification of tissue injury from a rattlesnake bite is critical to prevent
complications and reduce health care costs. Given the limitations of clinical assessment,
there is a need to develop a more objective reproducible, anatomically detailed diagnostic
tool for to accurately assess tissue damage and assist with timely administration of
antivenom, if needed. Emergency physician performed point-of-care ultrasonography has been
shown to be beneficial in the diagnosis and management of skin and soft tissue infections.
The innovative use of bedside ultrasound technology can provide new information to
individualize antivenom treatment and to improve patient outcomes. The quick, noninvasive
nature and repeatability of point-of-care ultrasonography makes it an ideal objective tool
for the assessment of emergency department (ED) patients with rattle snakebites. Ultrasound
technology can reveal subcutaneous edema, localized fluid collections, tissue necrosis, and
muscle contractions resulting from a rattlesnake bite.6 Point-of-care ultrasonography
performed by emergency physicians can detect the tissue injury that is not evident on
clinical assessment and accurately track the patterns of injury prior to their external
manifestations. This innovative approach can expedite treatment in patients with rattle snake
envenomation thereby preventing complications such as coagulopathy (a condition in which the
blood's ability to clot is impaired) and compartment syndrome (excessive pressure build up
inside an enclosed space in the body). Additionally ultrasound can eliminate the
inappropriate use of antivenom in patients with dry bite potentially reducing health care
costs and improving patient safety.
Our preliminary experience and prior literature suggests that point-of-care ultrasound can
detect subcutaneous edema, help clinicians to make an accurate assessment of proximal
progression of local findings due to a snake bite and can expedite the consultation and
appropriate treatment in patients with snake bite.The objectives of this study is to compare
clinical assessment and bedside ultrasound findings in the detection of tissue injury in
emergency department patients with rattle snakebite and determine if bedside ultrasound can
alter management (antivenom dosing) in emergency department patients with rattle snakebite.
