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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02185521
Other study ID # 2917-05-12-433
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2016
Est. completion date November 18, 2016

Study information

Verified date May 2019
Source Philips Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 127
Est. completion date November 18, 2016
Est. primary completion date November 18, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
patient assessment
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.

Locations

Country Name City State
United States Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit 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

Sponsors (2)

Lead Sponsor Collaborator
Philips Healthcare Philips Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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..
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