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

Not Applicable

• Conditions: Patients Who Are in Shock and Intubated in the Trauma Bay (TB)
• Interventions: Other: Usual care; Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)

• Registration Number: NCT02218983
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-17
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine
Limited transthoracic echocardiogram (LTTE)	Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)	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

Primary Outcome Measures

Name	Time	Method
length of stay in the intensive care unit	length of stay in the intensive care unit, not to exceed 30 days

Secondary Outcome Measures

Name	Time	Method
mortality (death)	mortality (death) during hospital stay, not to exceed 30 days

Trial Locations

Locations (1)

Riverside County Regional Medical Center; 🇺🇸 Moreno Valley, California, United States