AzTrials
AzTrials

Hemodynamic InstabilityNCT01838343

Efficacy of Ultrasound to Guide Management During a Rapid Response Event

A study testing Ultrasound in people with Hemodynamic Instability and Respiratory Failure, run by Beth Israel Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodynamic Instability, Respiratory Failure
What is being tested?
Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Mar 2013to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  1. 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beth Israel Medical Center

    New York, New York, 10003

Other trials in United States

About this study

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.

Read the 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.

Being tested
Ultrasound
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundOther

    Also called Ultrasound to be performed by GE Vscan.

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

Study groups in NCT01838343
Study groupRoleWhat they receive
No UltrasoundNo interventionPatients randomized to no ultrasound will get standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.
UltrasoundExperimentalPatients 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.
Receives: Other: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in shock

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

    Measured: Immediately after rapid response

  2. Time in respiratory failure

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

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

Secondary outcomes (6)
  1. Mortality

    Death during the hospitalization that the rapid response occured during.

    Measured: During hospitaliztion or for 8 weeks thereafter.

  2. Diagnosis variation following ultrasound

    Agreement between pre-ultrasound and post-ultrasound diagnosis.

    Measured: Immediately after ultrasound and for 1 day thereafter.

  3. Utilization of chest x-ray

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

    Measured: Following rapid response event and one day thereafter.

  4. Utilization of CT scan

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

    Measured: Following rapid response event for one day thereafter.

  5. Length of stay

    Hospital length of stay following rapid response event.

    Measured: Following rapid response event and for 8 weeks thereafter.

  6. Management changes following ultrasound performance

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

    Measured: Immediately following ultrasound and for one day thereafter.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01838343
Sponsor's protocol ID
218-12
Status last verified
Dec 2014
First submitted
5 Apr 2013
Last updated
31 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Hemodynamic Instability and Respiratory Failure, run by Beth Israel Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in shock (time frame: Immediately after rapid response). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in