Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging

Study Overview
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Brief Summary
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At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. However, CTA has risks including contrast- induced allergic reactions and nephropathy, as well as radiation which has been linked to development of cancer later in life. There is literature that has looked at using lower extremity doppler ultrasound first to evaluate for a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also literature showing that emergency medicine physicians can perform adequate lower extremity compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound tech. The goal of this project is to fuse both principles by having emergency medicine physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of PE.

Detailed Description
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In this study, the subgroup of hemodynamically stable patients felt to be at moderate to high risk for PE will receive a bilateral LCUS before possible CTA/VQ imaging. The LCUS of the entire proximal leg including the popliteal fossa will be performed by an emergency medicine resident provider in conjunction with their attending. All positive studies will then be confirmed with a second ultrasound by the Albany Medical Center's vascular laboratory service. Patients with confirmed acute positive studies identifying a DVT will be treated for a presumed PE, which is the same treatment as that for the DVT. No CTA will be ordered from the ED. They will be anticoagulated and admitted to the hospital, with further management as per the inpatient hospital team. Patients with a negative emergency department LCUS done by the resident will receive either a CTA or a VQ (ventilation/perfusion) scan as per the initial treatment plan established by the attending physician. According to this protocol, patients discharged home by default must have had a negative CTA or VQ scan, and so PE was effectively ruled out. Therefore they will not require further follow up after discharge. However, we will follow patients who were admitted throughout their admission course. Through review of medical records, we will take note of any complications such as any issues with starting anticoagulation treatment without a CTA, misdiagnoses, whether a CTA was ordered later as a part of their course and why, and further details.

Official Title
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Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging

Conditions
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Pulmonary Embolism, Deep Vein Thrombosis Leg, Ultrasound Imaging

Intervention / Treatment
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* Diagnostic Test: Lower extremity Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Concern for PE (moderate to high risk) that warrants imaging of the chest Exclusion Criteria: Age less than 18 nidus for DVT in upper extremity (eg. PICC (peripherally inserted central Cather) line, etc) already anti-coagulated at presentation above the knee- leg cast prisoners DVT ultrasound or CTA prior to presentation Hemodynamically unstable: SBP (systolic blood pressure) <90 for >15min Drop of SBP by at least 40mmHG for >15mins Organ hypoperfusion (eg cold extremities, mental confusion, low urine outpt <30cc/hr, etc need for pressors Other concerns in thorax necessitating inevitable CT chest imaging.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: In all enrolled patients with concern for pulmonary embolism, a lower extremity ultrasound will be performed at the patient's bedside by the emergency room provider. If it is positive for a deep vein thrombosis, then a confimatory ultrasound will be performed by the vascular lab, and the patient started on anticoagulation to treat both the DVT and presumed PE. No CTA will be obtained in this group. Everyone else who had a negative bedside ultrasound performed by the ER provider will not receive a second ultrasound, but will rather go on to get the CT angiogram of the chest they would have likely received if not in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Positive lower extremity ultrasound<br>This group found to to have a deep venous thrombosis on lower extremity ultrasound will not have a CT of the chest ordered from the emergency department, and will be treated for the DVT and presumed PE. | Diagnostic Test: Lower extremity Ultrasound<br>* One group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging.<br>* Other names: CT angiogram of the chest;|
| Other: Negative lower extremity ultrasound<br>This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest . | Diagnostic Test: Lower extremity Ultrasound<br>* One group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging.<br>* Other names: CT angiogram of the chest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute reduction in CT imaging to diagnose PE | With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment. | for duration of the study,about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential reduction in CT imaging to diagnose PE | If a CT is ordered on a patient with a positive lower extremity ultrasound by an inpatient physician later during the admission, we will calculate what the reduction in CT imaging would have been if the protocol had been followed to the end. | for duration of the study, about 1 year | 
| Time to start of treatment | The use of bedside ultrasound may allow for making a diagnoses more quickly, and therefore potentially starting treatment sooner. | for duration of the study , about 1 year | 
| Cost-analysis | The use of ultrasound may have less cost than using a CT scan | for duration of study, about 1 year |