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

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ClinicalTrials.gov Identifier: NCT02218983
Recruitment Status : Unknown
Verified April 2017 by Aron Depew, MD, Riverside University Health System Medical Center.
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Aron Depew, MD, Riverside University Health System Medical Center

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Patients Who Are in Shock and Intubated in the Trauma Bay (TB) Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound) Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. length of stay in the intensive care unit [ Time Frame: length of stay in the intensive care unit, not to exceed 30 days ]

Secondary Outcome Measures :
  1. mortality (death) [ Time Frame: mortality (death) during hospital stay, not to exceed 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT02218983


Contacts
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Contact: Aron Depew, MD 951-486-5857 adepew@co.riverside.ca.us
Contact: Hayley S Lee, MPH 951-486-5857 haylee@co.riverside.ca.us

Locations
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United States, California
Riverside County Regional Medical Center Recruiting
Moreno Valley, California, United States, 92555
Contact: Aron Depew, MD    951-486-5857    adepew@co.riverside.ca.us   
Contact: Hayley Lee, MPH    951-486-5857    haylee@co.riverside.ca.us   
Principal Investigator: Aron Depew, MD         
Sponsors and Collaborators
Riverside University Health System Medical Center
Investigators
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Principal Investigator: Aron Depew, MD Riverside University Health System Medical Center
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Responsible Party: Aron Depew, MD, Principal Investigator, Riverside University Health System Medical Center
ClinicalTrials.gov Identifier: NCT02218983    
Other Study ID Numbers: 620651
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Keywords provided by Aron Depew, MD, Riverside University Health System Medical Center:
trauma
echo
echocardiogram
ultrasound
inferior vena cava collapsibility
Additional relevant MeSH terms:
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