The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02218983|
Recruitment Status : Unknown
Verified April 2017 by Aron Depew, MD, Riverside University Health System Medical Center.
Recruitment status was: Recruiting
First Posted : August 18, 2014
Last Update Posted : April 17, 2017
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.
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?
- Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality).
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Patients Who Are in Shock and Intubated in the Trauma Bay (TB)||Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound) Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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
Device: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
Active Comparator: Usual care
measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine
Other: Usual care
- length of stay in the intensive care unit [ Time Frame: length of stay in the intensive care unit, not to exceed 30 days ]
- mortality (death) [ Time Frame: mortality (death) during hospital stay, not to exceed 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218983
|Contact: Aron Depew, MDemail@example.com|
|Contact: Hayley S Lee, MPHfirstname.lastname@example.org|
|United States, California|
|Riverside County Regional Medical Center||Recruiting|
|Moreno Valley, California, United States, 92555|
|Contact: Aron Depew, MD 951-486-5857 email@example.com|
|Contact: Hayley Lee, MPH 951-486-5857 firstname.lastname@example.org|
|Principal Investigator: Aron Depew, MD|
|Principal Investigator:||Aron Depew, MD||Riverside University Health System Medical Center|