Efficacy of Ultrasound to Guide Management During a Rapid Response Event

NCT01838343 | Completed

• 1 other identifier: 218-12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• Time in shock

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

  Immediately after rapid response

• Time in respiratory failure

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

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

Secondary Outcomes (6)

• Mortality

  During hospitaliztion or for 8 weeks thereafter.

• Diagnosis variation following ultrasound

  Immediately after ultrasound and for 1 day thereafter.

• Utilization of chest x-ray

  Following rapid response event and one day thereafter.

• Utilization of CT scan

  Following rapid response event for one day thereafter.

• Length of stay

  Following rapid response event and for 8 weeks thereafter.

Study Arms (2)

No Ultrasound

NO INTERVENTION

Patients randomized to no ultrasound will get standard diagnostic and therapeutic interventions that are clinically indicated during the rapid response event.

Ultrasound

EXPERIMENTAL

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.

Other: Ultrasound

Interventions

Ultrasound OTHER

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

Also known as: Ultrasound to be performed by GE Vscan.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Are not hemodynamically unstable and not in respiratory failure.
• Are hemodynamically unstable but who have an obvious source of bleeding to explain hemodynamic instability.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 24, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (1)