Efficacy of Ultrasound to Guide Management During a Rapid Response Event
Primary Purpose
Hemodynamic Instability, Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hemodynamic Instability
Eligibility Criteria
Inclusion Criteria: Patients for whom a rapid response is called who have:
Hemodynamic instability as defined by:
- Systolic blood pressure less than 90 mmHg or less than 40 mmHg from previously established baseline
- Heart rate greater than 130 beats per minute
- Known elevated lactate above normal value.
- Hypercapnic or hypoxemic respiratory failure as judged by the responding critical care fellow.
Exclusion Criteria: Patients for whom a rapid response has been called who:
- Are not hemodynamically unstable and not in respiratory failure.
- Are hemodynamically unstable but who have an obvious source of bleeding to explain hemodynamic instability.
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Ultrasound
Ultrasound
Arm Description
Patients randomized to no ultrasound will get standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.
Patients randomized to ultrasound will get a goal-directed ultrasound performed by a critical care fellow along with standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.
Outcomes
Primary Outcome Measures
Time in shock
Time on vasopressors following the rapid response event and for 8 weeks thereafter.
Time in respiratory failure
Time period that the patient requires invasive or non-invasive mechanical ventilation.
Secondary Outcome Measures
Mortality
Death during the hospitalization that the rapid response occured during.
Diagnosis variation following ultrasound
Agreement between pre-ultrasound and post-ultrasound diagnosis.
Utilization of chest x-ray
Frequency of chest x-ray performance will be measured during the 24 hours immediately following the rapid response event.
Utilization of CT scan
Frequency of CT scan performance will be measured during the 24 hours immediately following the rapid response event.
Length of stay
Hospital length of stay following rapid response event.
Management changes following ultrasound performance
Pre-ultrasound and post-ultrasound management will be documented.
Full Information
NCT ID
NCT01838343
First Posted
April 5, 2013
Last Updated
December 29, 2014
Sponsor
Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01838343
Brief Title
Efficacy of Ultrasound to Guide Management During a Rapid Response Event
Official Title
Efficacy of Ultrasound to Guide Management During a Rapid Response Event
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rapid response team systems have been implemented in numerous hospitals throughout the world with the goal of improving the identification and safety of hospitalized patients who are clinically deteriorating. Despite their theoretical benefit, rapid response systems have not been proven in the medical literature to ultimately change outcomes.
The traditional physical exam is helpful in evaluating and treating unstable medical patients during these types of events but has significant limitations of deceased sensitivity and specificity of findings. Ultrasound is a known tool for more accurately assessing patients in shock and respiratory failure in the ICU by highly trained operators but to the investigators knowledge has not been studied in the setting of rapid response events on hospital wards by critical care fellows after focused training. The investigators aim to assess the impact of ultrasound performed by critical care fellows during rapid response events.
Detailed Description
This is an randomized controlled trial to determine if portable critical care ultrasound use is feasible, if its findings change clinical decision making by critical care fellows and whether ultrasound can improve patient outcomes during rapid response events at Beth Israel Medical Center.
Patients for whom a rapid response has been called for cardiac or respiratory failure will be randomized to either have a bedside ultrasound performed by a critical care fellow at the time of rapid response or to undergo a bedside ultrasound only if clinically indicated and specifically requested by the RRT leader.
For all patients on whom a rapid response is called with shock or respiratory failure who are randomized to the intervention group, a designated ultrasound critical care fellow will document their ranked top 2 preliminary cause for either shock or respiratory failure on a data collection instrument (DCI). These clinical (i.e. pre-ultrasound) diagnoses will be based on history, physical exam and all ancillary testing available prior to ultrasound performance. Available ancillary testing will be documented.
An ultrasound exam will then be performed by the designated ultrasound fellow using a portable hand-carried unit (GE Vscan) and the findings documented on the same DCI. The GE Vscan will be used for all ultrasounds performed during this study. The ultrasound study will take approximately 5 -10 minutes and will not interfere with alternative evaluation or treatment modalities deemed to be necessary during the rapid response.
The critical care ultrasound fellow will then provide the RRT leader team with their 2 most likely post ultrasound diagnosis for shock and respiratory failure and then document these on the DCI. Any changes to management made as a result of the ultrasound exam, including all new ancillary tests and therapeutic interventions will be recorded.
At 72 hours following the initial event the ICU or general medical attending physician will be asked to document the "final" diagnosis as to the cause of the initial shock or respiratory failure. This "final" diagnosis will serve as the "gold standard" to allow the assessment of accuracy of the pre-ultrasound and post-ultrasound diagnoses.
Patients randomized to the standard care group will not have an ultrasound performed at the time of rapid response unless it is deemed medically necessary by the responding RRT leader or critical care fellow. This is the current practice approach at the investigators hospital where ultrasound is performed only when clinically indicated.
The study investigators will obtain all DCI's as well as the final diagnosis from the attending physician at 72 hours, and will enter this data into a database that will not contain any unique patient identifiers.
The patient's time in respiratory failure and time in shock will be recorded as primary outcome measures. Secondary outcomes of in-hospital mortality, utilization of CT scan and chest x-ray in the 24 hours following rapid response and hospital length of stay will also be recorded. Also measured will be variability in pre and post-ultrasound diagnosis as well as changes in management following ultrasound performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Respiratory Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Ultrasound
Arm Type
No Intervention
Arm Description
Patients randomized to no ultrasound will get standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Patients randomized to ultrasound will get a goal-directed ultrasound performed by a critical care fellow along with standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
Ultrasound to be performed by GE Vscan.
Intervention Description
Goal-directed ultrasound using a GE Vscan performed by a critical care fellow trained in ultrasonography.
Primary Outcome Measure Information:
Title
Time in shock
Description
Time on vasopressors following the rapid response event and for 8 weeks thereafter.
Time Frame
Immediately after rapid response
Title
Time in respiratory failure
Description
Time period that the patient requires invasive or non-invasive mechanical ventilation.
Time Frame
From immediately after rapid response event and for 8 weeks thereafter.
Secondary Outcome Measure Information:
Title
Mortality
Description
Death during the hospitalization that the rapid response occured during.
Time Frame
During hospitaliztion or for 8 weeks thereafter.
Title
Diagnosis variation following ultrasound
Description
Agreement between pre-ultrasound and post-ultrasound diagnosis.
Time Frame
Immediately after ultrasound and for 1 day thereafter.
Title
Utilization of chest x-ray
Description
Frequency of chest x-ray performance will be measured during the 24 hours immediately following the rapid response event.
Time Frame
Following rapid response event and one day thereafter.
Title
Utilization of CT scan
Description
Frequency of CT scan performance will be measured during the 24 hours immediately following the rapid response event.
Time Frame
Following rapid response event for one day thereafter.
Title
Length of stay
Description
Hospital length of stay following rapid response event.
Time Frame
Following rapid response event and for 8 weeks thereafter.
Title
Management changes following ultrasound performance
Description
Pre-ultrasound and post-ultrasound management will be documented.
Time Frame
Immediately following ultrasound and for one day thereafter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients for whom a rapid response is called who have:
Hemodynamic instability as defined by:
Systolic blood pressure less than 90 mmHg or less than 40 mmHg from previously established baseline
Heart rate greater than 130 beats per minute
Known elevated lactate above normal value.
Hypercapnic or hypoxemic respiratory failure as judged by the responding critical care fellow.
Exclusion Criteria: Patients for whom a rapid response has been called who:
Are not hemodynamically unstable and not in respiratory failure.
Are hemodynamically unstable but who have an obvious source of bleeding to explain hemodynamic instability.
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
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Efficacy of Ultrasound to Guide Management During a Rapid Response Event
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