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

NCT ID: NCT02218983

Last Updated: 2017-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)

Intervention Type DEVICE

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Interventions

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Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)

Intervention Type DEVICE

Usual care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riverside University Health System Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Aron Depew, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aron Depew, MD

Role: PRINCIPAL_INVESTIGATOR

Riverside University Health System Medical Center

Locations

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Riverside County Regional Medical Center

Moreno Valley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aron Depew, MD

Role: CONTACT

951-486-5857

Hayley S Lee, MPH

Role: CONTACT

951-486-5857

Facility Contacts

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Aron Depew, MD

Role: primary

951-486-5857

Hayley Lee, MPH

Role: backup

951-486-5857

Other Identifiers

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620651

Identifier Type: -

Identifier Source: org_study_id

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