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Initial main phase completed but recruitment rate was too slow to continue.
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| Name | Class |
|---|---|
| Philips Electronics Nederland B.V. acting through Philips CTO organization | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
If a Legally Authorized Representative (LAR) consented on behalf of the participant and later the participant had the capacity to self-consent and decided not to participate in the study, the participant was dropped from the study.
All patients admitted to the surgical, trauma and burn ICU were evaluated for inclusion/exclusion criteria. Those who met eligibility were approached for informed consent. Legally Authorized Representatives (LAR's) were approached for patients who were too injured or ill to participate in the informed consent process.
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| ID | Title | Description |
|---|---|---|
| FG000 | Visible HII - Patient Assessment | Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment. Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Visible HII - Patient Assessment | Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment. Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intensive Care Unit (ICU) Length of Stay | Posted | Mean | Standard Deviation | days | 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. |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visible HII - Patient Assessment | Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment. Patient assessment: Patient clinician status assessment based on HII trend. The HII indicator combines existing data such as physiologic parameters (HR, BP), laboratory measurements (Albumin, HCT, Bicarbonate, WBC, BUN), and ADT information (age). HII will be displayed on charting workstation (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. |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Szymon Bieganski | Philips Healthcare | 978-284-3271 | szymon.bieganski@philips.com |
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| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D063868 | Patient Outcome Assessment |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit | Providence | Rhode Island | 02903 | United States |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Treatment | Number | participants |
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| Surgical Type | Count of Participants | Participants |
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| Monitoring - Arterial line | Count of Participants | Participants |
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| Secondary | Intensive Care Unit (ICU) Mortality | Posted | Count of Participants | Participants | From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days.. |
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| 12 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
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| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |