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

NCT02185521 | Terminated Results DMC

• 1 other identifier: 2917-05-12-433
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 2

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.

Conditions

Shock; Hemodynamic Instability

Keywords

Hemodynamics; Medical Informatics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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..

Study Arms (1)

visible HII - patient assessment

EXPERIMENTAL

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.

Other: patient assessment

Interventions

patient assessment OTHER

Patient clinician status assessment based on Hemodynamic Instability Indicator (HII) trend. The HII indicator combines existing data such as physiologic parameters (Heart Rate, HR; Blood Pressure, BP), laboratory measurements (Albumin; Hematocrit, HCT; Bicarbonate; White Blood Cell, WBC; Blood Urea Nitrogen, BUN), and ADT information (age). HII will be displayed on charting workstation (Workstation on Wheels, WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII.

visible HII - patient assessment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Healthcare: lead
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (2)

Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery

St Louis, Missouri, 63110-1093, United States

Location

Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Shock

Interventions

Patient Outcome Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Slow recruitment led to early termination of the study; generalizability to other ICU settings; lack of further analyses due to small sample size and data collected (timing of intervention, morbidity, cost reduction).

Results Point of Contact

• Title: Dr. Szymon Bieganski
• Organization: Philips Healthcare

szymon.bieganski@philips.com

978-284-3271

Study Officials

• Grant V Bochicchio, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Mitchell M Levy, MD

  Alpert Medical School of Brown University, Rhode Island Hospital, Providence RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 9, 2014
• Study Start: March 1, 2016
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: June 11, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Locations

US (2)