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

NCT03532165 | Unknown

• 1 other identifier: 4975
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism; Deep Vein Thrombosis Leg; Ultrasound Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Potential reduction in CT imaging to diagnose PE

  for duration of the study, about 1 year

• Time to start of treatment

  for duration of the study , about 1 year

• Cost-analysis

  for duration of study, about 1 year

Study Arms (2)

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.

Diagnostic Test: Lower extremity Ultrasound

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 .

Diagnostic Test: Lower extremity Ultrasound

Interventions

Lower extremity Ultrasound DIAGNOSTIC_TEST

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.

Also known as: CT angiogram of the chest

Negative lower extremity ultrasound; Positive lower extremity ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center Department of Emergency Medicine

Albany, New York, 12208, United States

RECRUITING

Related Publications (4)

• Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.

  PMID: 24024223 BACKGROUND

• 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.

  PMID: 27377039 BACKGROUND

• 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.

  PMID: 14984813 BACKGROUND

• 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.

  PMID: 25269577 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Dorcas B Pinto, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorcas B Pinto, MD

CONTACT

518-262-3773; PintoD@amc.edu

Beth Cadigan, MD

CONTACT

518-262-3773; CadigaB@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 22, 2018
• Study Start: April 2, 2018
• Primary Completion: February 22, 2019
• Study Completion: February 28, 2019
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)