Recruiting

LTTE

Sponsor:

Riverside University Health System Medical Center

Code:

NCT02218983

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)

Usual care

Study Details

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).

Conditions

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

Study ID

NCT02218983

Start date

Jun, 2014

Status verified date

Apr, 2017

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Limited transthoracic echocardiogram (LTTE)

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

active comparator: Usual care

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

Interventions

Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)

Usual care

Primary outcome measure

  • length of stay in the intensive care unit [ Time Frame: length of stay in the intensive care unit, not to exceed 30 days ]

Central Contacts and Locations

Locations

Riverside County Regional Medical Center

Recruiting

Moreno Valley, California, United States, 92555

Contacts

Principal Investigator:

Aron Depew, MD

More Information

Sponsor

Riverside University Health System Medical Center

Last update posted

Apr 17, 2017

Last verified

Apr, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Riverside University Health System Medical Center on 2017-04-17.