Patients Who Are in Shock and Intubated in the Trauma Bay (TB) Clinical Trial
Official title:
The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation
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).
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Riverside County Regional Medical Center | Moreno Valley | California |
| Lead Sponsor | Collaborator |
|---|---|
| Riverside County Regional Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | length of stay in the intensive care unit | length of stay in the intensive care unit, not to exceed 30 days | ||
| Secondary | mortality (death) | mortality (death) during hospital stay, not to exceed 30 days |