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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532165
Recruitment Status : Unknown
Verified May 2018 by Dorcas Boahema Pinto, Albany Medical College.
Recruitment status was:  Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dorcas Boahema Pinto, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Deep Vein Thrombosis Leg Ultrasound Imaging Diagnostic Test: Lower extremity Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : February 22, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: CT angiogram of the chest

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 Name: CT angiogram of the chest




Primary Outcome Measures :
  1. Absolute reduction in CT imaging to diagnose PE [ Time Frame: 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.


Secondary Outcome Measures :
  1. Potential reduction in CT imaging to diagnose PE [ Time Frame: for duration of the study, about 1 year ]
    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.

  2. Time to start of treatment [ Time Frame: for duration of the study , about 1 year ]
    The use of bedside ultrasound may allow for making a diagnoses more quickly, and therefore potentially starting treatment sooner.

  3. Cost-analysis [ Time Frame: for duration of study, about 1 year ]
    The use of ultrasound may have less cost than using a CT scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532165


Contacts
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Contact: Dorcas B Pinto, MD 518-262-3773 PintoD@amc.edu
Contact: Beth Cadigan, MD 518-262-3773 CadigaB@amc.edu

Locations
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United States, New York
Albany Medical Center Department of Emergency Medicine Recruiting
Albany, New York, United States, 12208
Contact: Dorcas B Pinto, MD    518-262-3773    PintoD@amc.edu   
Contact: Beth Cadigan, MD    518-262-3773    CadigaB@amc.edu   
Principal Investigator: Dorcas B Pinto, MD         
Principal Investigator: Beth Cadigan, MD         
Sub-Investigator: Sean Donovan, MBCHB         
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Dorcas B Pinto, MD Albany Medical College
Publications:
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Responsible Party: Dorcas Boahema Pinto, Dr., Albany Medical College
ClinicalTrials.gov Identifier: NCT03532165    
Other Study ID Numbers: 4975
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Emergencies
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases