Recruiting

Bedside Ultrasound

Sponsor:

Albany Medical College

Code:

NCT03532165

Conditions

Pulmonary Embolism

Deep Vein Thrombosis Leg

Ultrasound Imaging

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lower extremity Ultrasound

Study Details

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

Study ID

NCT03532165

Start date

Apr 2, 2018

Status verified date

May, 2018

Completion date

Feb 28, 2019

Anticipated

Primary completion date

Feb 22, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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 .

Interventions

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.

Primary outcome measure

  • Absolute reduction in CT imaging to diagnose PE [ Time Frame: for duration of the study,about 1 year ]

Central Contacts and Locations

Central contacts

Dorcas B Pinto, MD

518-262-3773PintoD@amc.edu

Beth Cadigan, MD

518-262-3773CadigaB@amc.edu

Locations

Albany Medical Center Department of Emergency Medicine

Recruiting

Albany, New York, United States, 12208

Contacts

Dorcas B Pinto, MD

518-262-3773PintoD@amc.edu

Beth Cadigan, MD

518-262-3773CadigaB@amc.edu

Principal Investigator:

Dorcas B Pinto, MD

More Information

Sponsor

Albany Medical College

Last update posted

May 22, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2018-05-22.