Efficacy of Ultrasound to Guide Management During a Rapid Response Event
Status: | Completed |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | March 2013 |
End Date: | March 2015 |
Contact: | Daniel Fein, M.D. |
Email: | dfein@chpnet.org |
Phone: | 212-420-2655 |
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.
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.
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.
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.
Inclusion Criteria: Patients for whom a rapid response is called who have:
1. 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.
2. 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:
1. Are not hemodynamically unstable and not in respiratory failure.
2. Are hemodynamically unstable but who have an obvious source of bleeding to explain
hemodynamic instability.
We found this trial at
1
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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