Clinical trial NCT02218983: The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation
Official title: The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Who Are in Shock and Intubated in the Trauma Bay (TB)
Keywords: trauma
echo
echocardiogram
ultrasound
inferior vena cava collapsibility
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility 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.

Primary outcomes:
measure: length of stay in the intensive care unit
timeFrame: length of stay in the intensive care unit, not to exceed 30 days
Secondary outcomes:
measure: mortality (death)
timeFrame: mortality (death) during hospital stay, not to exceed 30 days
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: Riverside County Regional Medical Center
state: California
Study officials:
affiliation: Riverside University Health System Medical Center
name: Aron Depew, MD
role: PRINCIPAL_INVESTIGATOR
References: