Hemodynamic Instability Index: The Impact to Care With a New Predictive Indicator

Not Applicable

Terminated

Conditions: Hemodynamic Instability
Shock

Interventions: Other: patient assessment

Registration Number: NCT02185521

Lead Sponsor: Philips Healthcare

Brief Summary: Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill patients, who were not previously known to be at risk. This algorithm provides with the numerical index - Hemodynamic Instability Index (HII) and its trend which are calculated from existing real time data derived from patient's current hospital stay such as heart rate and blood pressure, labs, and Admission - Discharge- Transfer (ADT) data to help healthcare providers obtain information about patient's status and make clinical decisions.

The aim of the study is to determine if the patient clinical information, displayed in the form of HII, can prompt possible patient hemodynamic status change and trigger earlier clinical care team response. We hypothesize that this real-time information on hemodynamic instability and earlier clinical decision making will lead to reduced length of stay (LOS) and ICU mortality relative to standard care practice. Study will also identify if the use of the Philips new algorithm called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve outcomes for patients admitted to the intensive care units (ICUs).

During this study, upon patient admission to the ICU clinical data collection will begin. Data that will be pulled during the study includes: vital signs, medications, reason for admission to the ICU, treatments that patient may receive.

Research subjects will not be asked to do anything as far as specific activities expected to be accomplished during study participation. Subjects will be involved in the study only during their stay in ICU. HII information will be visible to clinicians, taking care of this patient only during his/ her stay in the study unit.

Study team will collect patient information and have the ability to view the HII for subjects.

Once patient leaves the ICU the study team will collect information on the remainder of patient's hospital course including date of hospital discharge. All collected data will be then fully de-identified and released to Philips for analysis.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 127

Inclusion Criteria

All patients admitted to the study unit will be invited to participate in the study.
Study subject has to stay in study unit for at least 12 hours.

Exclusion Criteria

Patients who were discharged from study unit earlier then 12 hours after admission.
Patients who are or become dependent on extracorporeal membrane oxygenation (ECMO) support.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
visible HII - patient assessment	patient assessment	Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system for individual subjects randomized into HII group arm. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) Length of Stay	From time of the study subject admission to the unit until the day of discharge of that same study subject from the unit, assessed up to 12 months.

Secondary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) Mortality	From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..

Trial Locations

Locations (2): Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery
🇺🇸
Saint Louis, Missouri, United States
Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit
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Providence, Rhode Island, United States
Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery
🇺🇸Saint Louis, Missouri, United States