BP Management System User Acceptance Testing

Study Overview
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Brief Summary
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This is a feasibility study for an investigational clinical decision support system (the System) intended to optimize the management of blood pressure (BP) for patients during vasopressor infusion. The investigational outcomes are the perceptions of the nurse-subjects who are managing the BP of the patient-subjects; the operational performance of the System; and any technical failures of the software during real-time operation.

Detailed Description
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This is a feasibility study for an investigational clinical decision support system (the System) intended to optimize the management of blood pressure (BP) for patients during vasopressor infusion. Enrollment is planned of a convenience sample of 20 individual patient-subjects and also the 20 nurse-subjects who correspond to the primary nurses managing the patient-subjects. Consent will be obtained by the investigative team from the patient-subject (or close family member or healthcare proxy) and from the nurse-subject. The nurse will receive training in the intended use and important limitations of the System. The System will be deployed to the patient's bedside and the System will be initiated. This intervention will continue for a duration of between 4 to 8 hours. A Technical Observer (TO) will be present to continually oversee the operation of the System, watching to ensure that there are no observable technical failures. The TO will also watch to see if any early termination conditions are met (specifically any concerns by the clinical staff or the patient or the patient's family; any observed technical operational problems; maximum dose vasopressors or hypoxia despite maximum respiratory support; or unplanned bedside response by the clinical care team) and also will make annotations about the exact time that specific clinical interventions are performed. After the intervention, the nurse-subject will be surveyed. Prior to enrollment of a subsequent subject, additional data analysis -- sufficient to identify or exclude any early stoppage condition -- will be performed on the System's archived electronic data and log files. Any adverse events will be reported to the IRB and the FDA as per FDA and institutional policy.

Official Title
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Live User Acceptance Testing of a Decision Support System to Optimize Blood Pressure Management During Critical Care

Conditions
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Hypotension and Shock

Intervention / Treatment
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* Device: VIGORIS Blood Pressure Management Clinical Decision Support System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (18 years or older) receiving continuous vasopressor infusion to maintain blood pressure; Clinician treating patient estimates future duration of vasopressor infusion likely at least 4 additional hours; Provider order has been made that sets lower limit for mean arterial pressure; Indwelling arterial catheter has been placed for continuous blood pressure monitoring. Exclusion Criteria: Lack of consent or at the discretion of the patient's primary nurse; The discretion of any of the patient's other clinical providers; People who do not speak English will be excluded. The rationale is that this protocol involves the bedside deployment of an investigational system plus longitudinal observation. Our mitigation for psychosocial risk involves a continual observer who can monitor for any evidence of subject psychosocial discomfort, which involves the ability to effectively communicate with the subject throughout the duration of the protocol. This therefore excludes patients who do not speak English. Patients who are on two simultaneous vasopressors running at maximum doses (per the ICUs own protocols) or who is on one maximum-dose vasopressor and has a contraindication to receiving a second vasopressor (e.g., insufficient vascular access). Patients who are hypoxic (SpO2 < 90%) despite maximum inspired oxygen (100% for patients receiving mechanical ventilation, or 10L high-flow in patients who are not candidates for mechanical ventilation). Provider order has been made that sets lower limit for SBP (because our system does not have the capability to provide decision-support for an SBP lower limit).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects | Device: VIGORIS Blood Pressure Management Clinical Decision Support System<br>* Software system to optimize tight blood pressure management during vasopressor infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative nurse-subject survey response | Nurse-subject quantitative survey response (yes/no) about any confusion or perceived inaccuracies of the system; perceived risk of patient management error; or perceived distraction that impacted care delivery | up to 8 hours | 
| Software operation (based on real-time observation) | System malfunction (yes/no) observed in real-time by the Technical Observer | up to 8 hours | 
| Data completeness | Completeness (yes/no) of flowsheet (data archive of the investigational System) without any lapses in input data from the bedside monitor during connectivity; and without lapses in associated BP forecasts. | up to 8 hours | 
| Software operation (based on review of error logs) | Error-level and critical-level software errors in the runtime log (yes/no) | up to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time that the BP forecast is operative (outcome 2.1) | Proportion of time (%) during the session when inclusion criteria were otherwise met that the BP forecast was operative (i.e., time intervals when no InOp criteria detected by the System leading to the InOp state) | up to 8 hours | 
| Accuracy of the MAP forecast (outcome 2.2) | Accuracy of the future 20 min median MAP forecast (average error between the MAP forecast and the future 20 min median MAP; for purposes of computing future 20 min median MAP, MAP < 10 mmHg and MAP > 250 mmHg is treated as a missing number) over time intervals during the session when inclusion criteria were otherwise met; the BP forecast was operative; and the analysis window criteria were met [at least 19 minutes remaining to the end of the record from the time of the forecast; and the analysis window has no more than 9 min of non-physiological MAP data (non-physiological MAP criteria are MAP < 10mmHg or MAP > 250mmHg or 'NaN')]. | up to 8 hours | 
| Proportion of time that the true future 20 min median MAP falls within the forecast cone (outcome 2.3) | Proportion of time (%) that the true future 20 min median MAP falls within the computed forecast cone over time intervals during the session when inclusion criteria were otherwise met; the BP forecast was operative; and the analysis window criteria were met [at least 19 minutes remaining to the end of the record from the time of the forecast; and the analysis window has no more than 9 min of non-physiological MAP data (non-physiological MAP criteria are MAP < 10mmHg or MAP > 250mmHg or 'NaN')] | up to 8 hours | 
| SHE incidence (outcome 3.1) | SHE incidence per 24 hrs [Sustained hypotensive event SHE is any interval commencing upon MAP < goal & 20-min future median MAP is also < goal; terminating upon time point when MAP >= goal and & 20-min future median MAP >= goal; SHEs occurring sequentially within 10 min are merged; any remaining SHEs not persisting at least 10 min are excluded] | up to 8 hours | 
| SHE proportion predicted by {Index > 35%} prior to earliest hypotension (outcome 3.2.1) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to the SHE's earliest hypotension [hypotension is defined as MAP < goal, with the exclusion of MAP < 10 mmHg, which is treated as a missing number]. Notification events are intervals that begin when there is an Index value that meets the notification criteria and terminate when there is an Index value output that does not meet the notification criteria. | up to 8 hours | 
| Advance warning times (AWTs) for SHEs predicted by {Index > 35%} prior to earliest hypotension (outcome 3.2.2) | AWTs (median) for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to the SHE's earliest hypotension [i.e., MAP < goal] | up to 8 hours | 
| SHE proportion predicted by {Index > user's Index threshold setting} prior to earliest hypotension (outcome 3.2.3) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to the SHE's earliest hypotension [i.e., MAP < goal] | up to 8 hours | 
| AWTs for SHEs predicted by {Index > user's Index threshold setting} prior to earliest hypotension (outcome 3.2.4) | AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to the SHE's earliest hypotension [i.e., MAP < goal] | up to 8 hours | 
| SHE proportion predicted by {Index > 35%} prior to continuous hypotension (outcome 3.3.1) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to continuous hypotension [intervals of ≥ 10 minutes of physiological MAP continuously below the hypotension threshold (physiological MAP are samples that do not meet the non-physiological criteria)] and excluding SHEs predicted prior to earliest hypotension | up to 8 hours | 
| AWTs for SHEs predicted by {Index > 35%} prior to continuous hypotension (outcome 3.3.2) | AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to continuous hypotension and excluding SHEs predicted prior to earliest hypotension | up to 8 hours | 
| SHE proportion predicted by {Index > user's Index threshold setting} prior to continuous hypotension (outcome 3.3.3) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to continuous hypotension and excluding SHEs predicted prior to earliest hypotension | up to 8 hours | 
| AWTs for SHEs predicted by {Index > user's Index threshold setting} prior to continuous hypotension (outcome 3.3.4) | AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to continuous hypotension and excluding SHEs predicted prior to earliest hypotension | up to 8 hours | 
| SHE proportion detected by {Index > 35%} after continuous hypotension onset (outcome 3.4.1) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > 35%) after onset of continuous hypotension | up to 8 hours | 
| AWTs for SHEs predicted by {Index > 35%} after continuous hypotension onset (outcome 3.4.2) | AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) after onset of continuous hypotension | up to 8 hours | 
| SHE proportion detected by {Index > user's Index threshold setting} after continuous hypotension onset (outcome 3.4.3) | SHE proportion (%) predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) after onset of continuous hypotension | up to 8 hours | 
| AWTs for SHEs predicted by {Index > user's Index threshold setting} after continuous hypotension onset (outcome 3.4.4) | AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) after onset of continuous hypotension | up to 8 hours | 
| SHE proportion with false resolutions (outcome 3.5.1) | SHE proportion with false resolutions [i.e., MAP >= goal transiently during SHE] | up to 8 hours | 
| Proportion of SHE false resolution episodes detected by {Index > 35%} (outcome 3.5.2) | proportion of SHE false resolutions with a contiguous notification event where {Index > 35%} | up to 8 hours | 
| Proportion of SHE false resolutions not detected by {Index > 35%} with InOp state during false resolution (outcome 3.5.3) | Proportion of SHE false resolutions that were not detected by {Index > 35%} and had InOp state occurring during the index false resolution episode | up to 8 hours | 
| Proportion of SHE false resolutions not detected by {Index > 35%} without InOp state during false resolution (outcome 3.5.4) | Proportion of SHE false resolutions that were not detected by {Index > 35%} and did not have InOp state occurring during the index false resolution episode | up to 8 hours | 
| Proportion of SHE false resolutions detected by {Index > user's Index threshold setting} (outcome 3.5.5) | proportion of SHE false resolutions with a contiguous notification event where {Index > user's Index threshold setting} | up to 8 hours | 
| Proportion of SHE false resolutions not detected by {Index > user's Index threshold setting} with InOp state during false resolution (outcome 3.5.6) | Proportion of SHE false resolutions that were not detected by {Index > user's Index threshold setting} and had InOp state occurring during the index false resolution episode | up to 8 hours | 
| Proportion of SHE false resolutions not detected by {Index > user's Index threshold setting} without InOp state during false resolution (outcome 3.5.7) | Proportion of SHE false resolutions that were not detected by {Index > user's Index threshold setting} and did not have InOp state occurring during the index false resolution episode | up to 8 hours | 
| Incidence of notification events {Index > 35%} that are contiguous with SHEs (outcome 3.6.1) | Incidence of notification events {Index > 35%} that are contiguous with SHEs, excluding notification events with onset during an SHE. | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} that are contiguous with SHEs (outcome 3.6.2) | Incidence of notification events {Index > user's Index threshold setting} that are contiguous with SHEs, excluding notification events with onset during an SHE | up to 8 hours | 
| Incidence of notification events {Index > 35%} that are sentinel notifications (outcome 3.6.3) | Incidence of notification events {Index > 35%} that are sentinel notifications [sentinel notification is a notification event that occurs within 60 min prior to an SHE; recorded dose increase; or during stuttering hypotension (defined in 3.7.1)], excluding notification events with onset during an SHE | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} that are sentinel notifications (outcome 3.6.4) | Incidence of notification events {Index > user's Index threshold setting} that are sentinel notifications, excluding notification events with onset during an SHE | up to 8 hours | 
| Incidence of notification events {Index > 35%} that are false notifications (outcome 3.6.5) | Incidence of notification events {Index > 35%} that are false notifications (defined as notification events not contiguous with an SHE and not a sentinel notification, excluding notification events with onset during an SHE | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} that are false notifications (outcome 3.6.6) | Incidence of notification events {Index > user's Index threshold setting} that are false notifications | up to 8 hours | 
| Incidence of notification events {Index > 35%} contiguous with an SHE false resolution (outcome 3.6.7) | Incidence of notification events {Index > 35%} contiguous with an SHE false resolution | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE false resolution (outcome 3.6.8) | Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE false resolution | up to 8 hours | 
| Incidence of notification events {Index > 35%} contiguous with an SHE true resolution, overall (outcome 3.6.9) | Incidence of notification events {Index > 35%} contiguous with an SHE true resolution | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution, overall (outcome 3.6.10) | Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution | up to 8 hours | 
| Incidence of notification events {Index > 35%} contiguous with an SHE true resolution, suppressible (outcome 3.6.11) | Incidence of notification events {Index > 35%} contiguous with an SHE true resolution after excluding all notification event interval that were within 8 min of a documented clinical intervention | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution, suppressible (outcome 3.6.12) | Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution after excluding all notification event interval that were within 8 min of a documented clinical intervention | up to 8 hours | 
| Incidence of notification events {Index > 35%} with onset during an SHE (outcome 3.6.13) | Incidence of notification events {Index > 35%} with onset during an SHE | up to 8 hours | 
| Incidence of notification events {Index > user's Index threshold setting} with onset during an SHE (outcome 3.6.14) | Incidence of notification events {Index > user's Index threshold setting} with onset during an SHE | up to 8 hours | 
| Duration of false notification events {Index > 35%} (outcome 3.6.15) | Median duration of false notification events {Index > 35%} | up to 8 hours | 
| Duration of false notification events {Index > user's Index threshold setting} (outcome 3.6.16) | Median duration of false notification events {Index > user's Index threshold setting} | up to 8 hours | 
| Stuttering hypotension incidence (outcome 3.7.1) | Stuttering hypotension incidence [Stuttering hypotension event commences upon hypotension and with >= 10 min of cumulative hypotension within subsequent 60 min; terminates upon next time point when onset condition is no longer met AND when MAP >= goal; intervals that qualify as an SHE are excluded from stuttering hypotension] | up to 8 hours | 
| Stuttering hypotension proportion detected by {Index > 35%} prior to the stuttering hypotension's first hypotension (outcome 3.7.2) | Proportion of stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension | up to 8 hours | 
| AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension (outcome 3.7.3) | AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension | up to 8 hours | 
| Stuttering hypotension proportion detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension (outcome 3.7.4) | Proportion of stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension | up to 8 hours | 
| AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension (outcome 3.7.5) | AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension | up to 8 hours | 
| Stuttering hypotension proportion detected by {Index > 35%} prior to 10 cumulative min of hypotension (outcome 3.7.6) | Proportion of stuttering hypotension episodes detected by {Index > 35%} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode (excluding episodes detected prior to first hypotension) | up to 8 hours | 
| AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to 10 cumulative min of hypotension (outcome 3.7.7) | AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to 10 cumulative min of hypotension | up to 8 hours | 
| Stuttering hypotension proportion detected by {Index > user's Index threshold setting} prior to 10 cumulative min of hypotension (outcome 3.7.8) | Proportion of stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode (excluding episodes detected prior to first hypotension) | up to 8 hours | 
| AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to 10 cumulative min of hypotension (outcome 3.7.9) | AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to 10 cumulative min of hypotension | up to 8 hours | 
| Stuttering hypotension proportion not detected by {Index > 35%} prior to 10 cumulative min of hypotension (outcome 3.7.10) | Proportion of stuttering hypotension episodes not detected by {Index > 35%} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode | up to 8 hours | 
| Stuttering hypotension proportion not detected by {Index > user's Index threshold setting} prior to 10 cumulative min of hypotension (outcome 3.7.11) | Proportion of stuttering hypotension episodes not detected by {Index > user's Index threshold setting} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode | up to 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasopressor, arterial blood pressure, clinical decision support system