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临床试验/NCT03532165
NCT03532165Unknown不适用

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

Albany Medical College2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Absolute reduction in CT imaging to diagnose PE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical Concern for PE (moderate to high risk) that warrants imaging of the chest

排除标准

  • 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.

研究组 & 干预措施

Positive lower extremity ultrasound

Other

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.

干预措施: Lower extremity Ultrasound (Diagnostic Test)

Negative lower extremity ultrasound

Other

This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest .

干预措施: Lower extremity Ultrasound (Diagnostic Test)

结局指标

主要结局

Absolute reduction in CT imaging to diagnose PE

时间窗: for duration of the study,about 1 year

With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment.

次要结局

  • Cost-analysis(for duration of study, about 1 year)
  • Time to start of treatment(for duration of the study , about 1 year)
  • Potential reduction in CT imaging to diagnose PE(for duration of the study, about 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorcas Boahema Pinto

Dr.

Albany Medical College

研究点 (2)

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