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Completed

NCT Number: NCT01838343

Efficacy of Ultrasound to Guide Management During a Rapid Response Event

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound

Other

Goal-directed ultrasound using a GE Vscan performed by a critical care fellow trained in ultrasonography.

Other names: Ultrasound to be performed by GE Vscan.

Primary outcomes

  1. Time in shock

    Time frame: Immediately after rapid response

    Time on vasopressors following the rapid response event and for 8 weeks thereafter.

  2. Time in respiratory failure

    Time frame: From immediately after rapid response event and for 8 weeks thereafter.

    Time period that the patient requires invasive or non-invasive mechanical ventilation.

Secondary outcomes

  1. Mortality

    Time frame: During hospitaliztion or for 8 weeks thereafter.

    Death during the hospitalization that the rapid response occured during.

  2. Diagnosis variation following ultrasound

    Time frame: Immediately after ultrasound and for 1 day thereafter.

    Agreement between pre-ultrasound and post-ultrasound diagnosis.

  3. Utilization of chest x-ray

    Time frame: Following rapid response event and one day thereafter.

    Frequency of chest x-ray performance will be measured during the 24 hours immediately following the rapid response event.

  4. Utilization of CT scan

    Time frame: Following rapid response event for one day thereafter.

    Frequency of CT scan performance will be measured during the 24 hours immediately following the rapid response event.

  5. Length of stay

    Time frame: Following rapid response event and for 8 weeks thereafter.

    Hospital length of stay following rapid response event.

  6. Management changes following ultrasound performance

    Time frame: Immediately following ultrasound and for one day thereafter.

    Pre-ultrasound and post-ultrasound management will be documented.

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2013
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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