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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism; Ultrasound Imaging; Deep Vein Thrombosis Leg
• Intervention / Treatment: Diagnostic test: Lower extremity Ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorcas B Pinto, MD; Phone Number: 518-262-3773; Email: PintoD@amc.edu
• Study Contact Backup: Name: Beth Cadigan, MD; Phone Number: 518-262-3773; Email: CadigaB@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center Department of Emergency Medicine
      • Contact: Dorcas B Pinto, MD; Phone Number: 518-262-3773; Email: PintoD@amc.edu
      • Contact: Beth Cadigan, MD; Phone Number: 518-262-3773; Email: CadigaB@amc.edu
      • Principal Investigator: Dorcas B Pinto, MD
      • Principal Investigator: Beth Cadigan, MD
      • Sub-Investigator: Sean Donovan, MBCHB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Positive lower extremity ultrasound; 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; 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.; Other Names: CT angiogram of the chest
Other: Negative lower extremity ultrasound; 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; 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.; Other Names: CT angiogram of the chest

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: Dorcas B Pinto, MD, Albany Medical College

Publications and helpful links

General Publications

• Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.
• Da Costa Rodrigues J, Alzuphar S, Combescure C, Le Gal G, Perrier A. Diagnostic characteristics of lower limb venous compression ultrasonography in suspected pulmonary embolism: a meta-analysis. J Thromb Haemost. 2016 Sep;14(9):1765-72. doi: 10.1111/jth.13407. Epub 2016 Aug 17.
• Perrier A, Roy PM, Aujesky D, Chagnon I, Howarth N, Gourdier AL, Leftheriotis G, Barghouth G, Cornuz J, Hayoz D, Bounameaux H. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med. 2004 Mar 1;116(5):291-9. doi: 10.1016/j.amjmed.2003.09.041.
• Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Anticipated): February 22, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: 4975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No