Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
Primary Purpose
Pulmonary Embolism, Deep Vein Thrombosis Leg, Ultrasound Imaging
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower extremity Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism
Eligibility Criteria
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.
Sites / Locations
- Albany Medical Center Department of Emergency MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Positive lower extremity ultrasound
Negative lower extremity ultrasound
Arm Description
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.
This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Time to start of treatment
The use of bedside ultrasound may allow for making a diagnoses more quickly, and therefore potentially starting treatment sooner.
Cost-analysis
The use of ultrasound may have less cost than using a CT scan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03532165
Brief Title
Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
Official Title
Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
February 22, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis Leg, Ultrasound Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive lower extremity ultrasound
Arm Type
Other
Arm Description
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.
Arm Title
Negative lower extremity ultrasound
Arm Type
Other
Arm Description
This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest .
Intervention Type
Diagnostic Test
Intervention Name(s)
Lower extremity Ultrasound
Other Intervention Name(s)
CT angiogram of the chest
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absolute reduction in CT imaging to diagnose PE
Description
With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment.
Time Frame
for duration of the study,about 1 year
Secondary Outcome Measure Information:
Title
Potential reduction in CT imaging to diagnose PE
Description
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.
Time Frame
for duration of the study, about 1 year
Title
Time to start of treatment
Description
The use of bedside ultrasound may allow for making a diagnoses more quickly, and therefore potentially starting treatment sooner.
Time Frame
for duration of the study , about 1 year
Title
Cost-analysis
Description
The use of ultrasound may have less cost than using a CT scan
Time Frame
for duration of study, about 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorcas B Pinto, MD
Phone
518-262-3773
Email
PintoD@amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Cadigan, MD
Phone
518-262-3773
Email
CadigaB@amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorcas B Pinto, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center Department of Emergency Medicine
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorcas B Pinto, MD
Phone
518-262-3773
Email
PintoD@amc.edu
First Name & Middle Initial & Last Name & Degree
Beth Cadigan, MD
Phone
518-262-3773
Email
CadigaB@amc.edu
First Name & Middle Initial & Last Name & Degree
Dorcas B Pinto, MD
First Name & Middle Initial & Last Name & Degree
Beth Cadigan, MD
First Name & Middle Initial & Last Name & Degree
Sean Donovan, MBCHB
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24024223
Citation
Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.
Results Reference
background
PubMed Identifier
27377039
Citation
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.
Results Reference
background
PubMed Identifier
14984813
Citation
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.
Results Reference
background
PubMed Identifier
25269577
Citation
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.
Results Reference
background
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Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
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