The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation

April 14, 2017 updated by: Aron Depew, MD, Riverside University Health System Medical Center

Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in critical care. First introduced for volume assessment in nephrology and cardiology, it is now being researched in emergency and critical care. Data is still evolving in its use in initial trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but utility of its measurement on U/S in the emergency department still has some controversy. In trauma specifically, small studies suggests benefit to the use of U/S to predict volume status, and most of these data are from one author. It is not known if this can be applied more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE, SonoSite Ultrasound) has been studied in several small studies, and only one small randomized controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one group, it is not known if it can be applied to all trauma populations.

Research question:

Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as well as or better than other methods of organ perfusion?

Hypotheses:

  1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality).
  2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator, number of and transfusions better than other methods of organ perfusion (tachycardia, hypotension, lactate, lactate clearance, creatinine, base deficit).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Moreno Valley, California, United States, 92555
        • Recruiting
        • Riverside County Regional Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aron Depew, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients arriving to trauma bay aged 18 or higher
  • Hypotensive (systolic blood pressure (SBP) < 90 mmHg or mean arterial pressure (MAP) < 65, on 2 measurements)
  • Respiratory failure (requiring mechanical ventilation)

Exclusion Criteria:

  • Unable to draw blood before transfusion or fluid challenge
  • Patient arrests within 10 minutes of arrival
  • Pregnant

Note: If inferior vena cava (IVC) not visible on ultrasound (U/S), pt will go to non-IVC group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Limited transthoracic echocardiogram (LTTE)
LTTE (SonoSite Ultrasound), which will be performed every 10 - 30 minutes, after each fluid challenge or transfusion, until two consecutive equivalent measurements are reached without fluid challenge or transfusion
Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
ACTIVE_COMPARATOR: Usual care
measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine
Other: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of stay in the intensive care unit
Time Frame: length of stay in the intensive care unit, not to exceed 30 days
length of stay in the intensive care unit, not to exceed 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality (death)
Time Frame: mortality (death) during hospital stay, not to exceed 30 days
mortality (death) during hospital stay, not to exceed 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riverside University Health System Medical Center

Investigators

  • Principal Investigator: Aron Depew, MD, Riverside University Health System Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (ESTIMATE)

August 18, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 620651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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