Hypotension and ShockNCT04688450
BP Management System User Acceptance Testing
A study testing VIGORIS Blood Pressure Management Clinical Decision Support System in people with Hypotension and Shock, run by Andrew Tomas Reisner at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension and Shock
- What is being tested?
- VIGORIS Blood Pressure Management Clinical Decision Support System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Enhanced respiratory precautions for COVID.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Live User Acceptance Testing of a Decision Support System to Optimize Blood Pressure Management During Critical Care
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.
Read the detailed description
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.
- Conditions
- Hypotension and Shock
- Being tested
- VIGORIS Blood Pressure Management Clinical Decision Support System
- Keywords
- vasopressor, arterial blood pressure, clinical decision support system
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIGORIS Blood Pressure Management Clinical Decision Support SystemDevice
Software system to optimize tight blood pressure management during vasopressor infusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects Receives: Device: VIGORIS Blood Pressure Management Clinical Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 8 hours
Software Operation (Based on Real-time Observation)
System malfunction (yes/no) observed in real-time by the Technical Observer
Measured: 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.
Measured: 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)
Measured: Up to 8 hours
Secondary outcomes (50)
Percentage of Time That the BP Forecast is Operative (Outcome 2.1)
Median percentage (%) of time, per patient, 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)
Measured: 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')].
Measured: Up to 8 hours
Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3)
Median percentage (%) of time, per patient, 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')]
Measured: 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]. [Clarification: We are reporting the mean "events per patient-day" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1)
Percentage (%) of total SHEs 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.
Measured: 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]. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.3)
Percentage (%) of total 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]
Measured: 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]. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.1)
Percentage (%) of total SHEs 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)]. NOTE: excluding SHEs predicted prior to earliest hypotension
Measured: 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. NOTE: A negative AWT denotes a notification event that occurs chronologically after the onset of the SHE event. For example, an AWT of -3 would mean the first notification event occurred 3 minutes after the onset of the SHE event, although still in advance of continuous hypotension.
Measured: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.3)
Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) 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)]. NOTE: excluding SHEs predicted prior to earliest hypotension
Measured: 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. NOTE: A negative AWT denotes a notification event that occurs chronologically after the onset of the SHE event. For example, an AWT of -3 would mean the first notification event occurred 3 minutes after the onset of the SHE event, although still in advance of continuous hypotension.
Measured: Up to 8 hours
Percentage of Total SHEs Detected by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.1)
Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) after onset of continuous hypotension
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total SHEs Detected by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.3)
Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) after onset of continuous hypotension
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total SHEs With False Resolutions (Outcome 3.5.1)
Percentage of total SHEs with false resolutions [i.e., MAP >= goal transiently during SHE]
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Detected by {Index > 35%} (Outcome 3.5.2)
Percentage (%) of total SHE false resolutions with a contiguous notification event where {Index > 35%}
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} With InOp State During False Resolution (Outcome 3.5.3)
Percentage of total SHE false resolutions that were not detected by {Index > 35%} and had InOp state occurring during the index false resolution episode
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} Without InOp State During False Resolution (Outcome 3.5.4)
Percentage (%) of total SHE false resolutions that were not detected by {Index > 35%} and did not have InOp state occurring during the index false resolution episode
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Detected by {Index > User's Index Threshold Setting} (Outcome 3.5.5)
Percentage (%) of total SHE false resolutions with a contiguous notification event where {Index > user's Index threshold setting}
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} With InOp State During False Resolution (Outcome 3.5.6)
Percentage (%) of total 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
Measured: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} Without InOp State During False Resolution (Outcome 3.5.7)
Percentage (%) of total 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
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: 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. [Clarification: We are using "notification events / patient-day (24h)" as the Unit of Measure for several reasons. First, different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: Up to 8 hours
Duration of False Notification Events {Index > 35%} (Outcome 3.6.15)
Median duration of false notification events {Index > 35%}
Measured: 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}
Measured: 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]. [Clarification: We are reporting the mean "events per patient-day" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.2)
Percentage (%) of total stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.4)
Percentage (%) of total stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.6)
Percentage (%) of total 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)
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.8)
Percentage (%) of total 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)
Measured: 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. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.10)
Percentage (%) of total stuttering hypotension episodes not detected by {Index > 35%} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode
Measured: Up to 8 hours
Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.11)
Percentage (%) of total 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
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start21 Jan 2021
- Primary completion31 May 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypotension and ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Tomas Reisner
- Sponsor type
- University, hospital or other
- Collaborators
- Nihon Kohden
- Responsible party
- Sponsor-investigator, Andrew Tomas Reisner, Massachusetts General Hospital
- Investigators
- Andrew T Reisner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688450
- Sponsor's protocol ID
- 2019P000837
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2020
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD may be shared if consistent with our institutional policy and approved by Nihon Kohden Innovation Center
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live User Acceptance Testing of a Decision Support System to Optimize Blood Pressure Management During Critical Care
- ClinicalTrials.gov ID
- NCT04688450
- Acronym / sponsor ID
- 2019P000837
- Conditions
- Hypotension and Shock
- Keywords
- vasopressor, arterial blood pressure, clinical decision support system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andrew Tomas ReisnerUniversity, hospital or other
- Collaborators
- Nihon Kohden
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: VIGORIS Blood Pressure Management Clinical Decision Support SystemThe investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIGORIS Blood Pressure Management Clinical Decision Support SystemSoftware system to optimize tight blood pressure management during vasopressor infusion | Device | Intervention group |
Primary outcome
Quantitative Nurse-subject Survey Response
Time frame: Up to 8 hours
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
Software Operation (Based on Real-time Observation)
Time frame: Up to 8 hours
System malfunction (yes/no) observed in real-time by the Technical Observer
Data Completeness
Time frame: Up to 8 hours
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.
Software Operation (Based on Review of Error Logs)
Time frame: Up to 8 hours
Error-level and critical-level software errors in the runtime log (yes/no)
50 secondary outcomes
Percentage of Time That the BP Forecast is Operative (Outcome 2.1)
Time frame: up to 8 hours
Accuracy of the MAP Forecast (Outcome 2.2)
Time frame: Up to 8 hours
Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3)
Time frame: Up to 8 hours
SHE Incidence (Outcome 3.1)
Time frame: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1)
Time frame: Up to 8 hours
Advance Warning Times (AWTs) for SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.2)
Time frame: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.3)
Time frame: Up to 8 hours
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.4)
Time frame: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.1)
Time frame: Up to 8 hours
AWTs for SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.2)
Time frame: Up to 8 hours
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.3)
Time frame: Up to 8 hours
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.4)
Time frame: Up to 8 hours
Percentage of Total SHEs Detected by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.1)
Time frame: Up to 8 hours
AWTs for SHEs Predicted by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.2)
Time frame: Up to 8 hours
Percentage of Total SHEs Detected by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.3)
Time frame: Up to 8 hours
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.4)
Time frame: Up to 8 hours
Percentage of Total SHEs With False Resolutions (Outcome 3.5.1)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Detected by {Index > 35%} (Outcome 3.5.2)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} With InOp State During False Resolution (Outcome 3.5.3)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} Without InOp State During False Resolution (Outcome 3.5.4)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Detected by {Index > User's Index Threshold Setting} (Outcome 3.5.5)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} With InOp State During False Resolution (Outcome 3.5.6)
Time frame: Up to 8 hours
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} Without InOp State During False Resolution (Outcome 3.5.7)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} That Are Contiguous With SHEs (Outcome 3.6.1)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Contiguous With SHEs (Outcome 3.6.2)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} That Are Sentinel Notifications (Outcome 3.6.3)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Sentinel Notifications (Outcome 3.6.4)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} That Are False Notifications (Outcome 3.6.5)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are False Notifications (Outcome 3.6.6)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} Contiguous With an SHE False Resolution (Outcome 3.6.7)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE False Resolution (Outcome 3.6.8)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.9)
Time frame: 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)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.11)
Time frame: 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)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > 35%} With Onset During an SHE (Outcome 3.6.13)
Time frame: Up to 8 hours
Incidence of Notification Events {Index > User's Index Threshold Setting} With Onset During an SHE (Outcome 3.6.14)
Time frame: Up to 8 hours
Duration of False Notification Events {Index > 35%} (Outcome 3.6.15)
Time frame: Up to 8 hours
Duration of False Notification Events {Index > User's Index Threshold Setting} (Outcome 3.6.16)
Time frame: Up to 8 hours
Stuttering Hypotension Incidence (Outcome 3.7.1)
Time frame: Up to 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD may be shared if consistent with our institutional policy and approved by Nihon Kohden Innovation Center
Related trials for Hypotension and Shock
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Enrolling by invitationPhase 4
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Vasodilatory Shock
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
RecruitingObservational study
Peripheral pULSe Assessment and Arterial pRessure (PULSAR)
Circulatory Shock, Hemodynamic Instability
RecruitingPhase 4
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew T Reisner, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIGORIS Blood Pressure Management Clinical Decision Support System in people with Hypotension and Shock, run by Andrew Tomas Reisner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Nurse-subject Survey Response (time frame: Up to 8 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.