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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
Usual care
Sponsored by
Riverside University Health System Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients Who Are in Shock and Intubated in the Trauma Bay (TB) focused on measuring trauma, echo, echocardiogram, ultrasound, inferior vena cava collapsibility

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riverside County Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Limited transthoracic echocardiogram (LTTE)

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

length of stay in the intensive care unit

Secondary Outcome Measures

mortality (death)

Full Information

First Posted
August 1, 2014
Last Updated
April 14, 2017
Sponsor
Riverside University Health System Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02218983
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riverside University Health System Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Who Are in Shock and Intubated in the Trauma Bay (TB)
Keywords
trauma, echo, echocardiogram, ultrasound, inferior vena cava collapsibility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Limited transthoracic echocardiogram (LTTE)
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine
Intervention Type
Device
Intervention Name(s)
Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
length of stay in the intensive care unit
Time Frame
length of stay in the intensive care unit, not to exceed 30 days
Secondary Outcome Measure Information:
Title
mortality (death)
Time Frame
mortality (death) during hospital stay, not to exceed 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aron Depew, MD
Phone
951-486-5857
Email
adepew@co.riverside.ca.us
First Name & Middle Initial & Last Name or Official Title & Degree
Hayley S Lee, MPH
Phone
951-486-5857
Email
haylee@co.riverside.ca.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aron Depew, MD
Organizational Affiliation
Riverside University Health System Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverside County Regional Medical Center
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aron Depew, MD
Phone
951-486-5857
Email
adepew@co.riverside.ca.us
First Name & Middle Initial & Last Name & Degree
Hayley Lee, MPH
Phone
951-486-5857
Email
haylee@co.riverside.ca.us
First Name & Middle Initial & Last Name & Degree
Aron Depew, MD

12. IPD Sharing Statement

Learn more about this trial

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

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