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

Study Overview
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Brief Summary
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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: Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality). 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).

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

Conditions
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Patients Who Are in Shock and Intubated in the Trauma Bay (TB)

Intervention / Treatment
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* Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limited transthoracic echocardiogram (LTTE)<br>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)<br> <br> |
| Active Comparator: Usual care<br>measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine | Other: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, echo, echocardiogram, ultrasound, inferior vena cava collapsibility