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

NCT02218983 | Unknown

• 1 other identifier: 620651
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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. 1.Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality).
2. 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).

Conditions

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

Keywords

trauma; echo; echocardiogram; ultrasound; inferior vena cava collapsibility

Outcome Measures

Primary Outcomes (1)

• length of stay in the intensive care unit

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

Secondary Outcomes (1)

• mortality (death)

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

Study Arms (2)

Limited transthoracic echocardiogram (LTTE)

EXPERIMENTAL

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)

Usual care

ACTIVE COMPARATOR

measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine

Other: Usual care

Interventions

Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound) DEVICE

Limited transthoracic echocardiogram (LTTE)

Usual care OTHER

Usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

Study Sites (1)

Riverside County Regional Medical Center

Moreno Valley, California, 92555, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Aron Depew, MD

  Riverside University Health System Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aron Depew, MD

CONTACT

951-486-5857; adepew@co.riverside.ca.us

Hayley S Lee, MPH

CONTACT

951-486-5857; haylee@co.riverside.ca.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 18, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (1)