Hemodynamic Instability, Shock
Conditions
Keywords
Hemodynamics, Medical Informatics
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.
Interventions
OTHERpatient 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.
Sponsors
Philips Electronics Nederland B.V. acting through Philips CTO organization
Philips Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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.. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Visible HII - Patient Assessment |
|---|---|
| Age, Continuous | 56 Years |
| Monitoring - Arterial line | 92 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 80 Participants |
| Surgical Type Elective | 9 Participants |
| Surgical Type N/A | 34 Participants |
| Surgical Type Unknown | 1 Participants |
| Surgical Type Urgent/Emergent | 81 Participants |
| Treatment Any hemodynamic intervention | 83 participants |
| Treatment Fluid resuscitation | 97 participants |
| Treatment Intraveneous (IV) med (inotropes/pressors) | 57 participants |
| Treatment Intraveneous (IV) med weak | 16 participants |
| Treatment No hemodynamic interventions | 16 participants |
| Treatment Packed Red Blood Cells (PRBC) | 69 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 127 |
| other Total, other adverse events | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Intensive Care Unit (ICU) Length of Stay
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visible HII - Patient Assessment | Intensive Care Unit (ICU) Length of Stay | 6.68 days | Standard Deviation 9.57 |
Secondary
Intensive Care Unit (ICU) Mortality
Time frame: From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Visible HII - Patient Assessment | Intensive Care Unit (ICU) Mortality | 12 Participants |