BP Management System User Acceptance Testing

January 23, 2025 updated by: Andrew Tomas Reisner

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).
  • Enhanced respiratory precautions for COVID.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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
Software system to optimize tight blood pressure management during vasopressor infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 8 hours
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
Up to 8 hours
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.
Up to 8 hours
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)
Up to 8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Time That the BP Forecast is Operative (Outcome 2.1)
Time Frame: up to 8 hours
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)
up to 8 hours
Accuracy of the MAP Forecast (Outcome 2.2)
Time Frame: Up to 8 hours
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
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
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')]
Up to 8 hours
SHE Incidence (Outcome 3.1)
Time Frame: Up to 8 hours
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.]
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
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.
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
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.
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
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]
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
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.
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
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
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
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.
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
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
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
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.
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
Percentage (%) of total SHEs 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)
Time Frame: Up to 8 hours
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.
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
Percentage (%) of total 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
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
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.
Up to 8 hours
Percentage of Total SHEs With False Resolutions (Outcome 3.5.1)
Time Frame: Up to 8 hours
Percentage of total SHEs with false resolutions [i.e., MAP >= goal transiently during SHE]
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 with a contiguous notification event where {Index > 35%}
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 that were not detected by {Index > 35%} and had InOp state occurring during the index false resolution episode
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 that were not detected by {Index > 35%} and did not have InOp state occurring during the index false resolution episode
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 with a contiguous notification event where {Index > user's Index threshold setting}
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 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
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
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
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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 > 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.]
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
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.]
Up to 8 hours
Duration of False Notification Events {Index > 35%} (Outcome 3.6.15)
Time Frame: Up to 8 hours
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)
Time Frame: Up to 8 hours
Median duration of false notification events {Index > user's Index threshold setting}
Up to 8 hours
Stuttering Hypotension Incidence (Outcome 3.7.1)
Time Frame: Up to 8 hours
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.]
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)
Time Frame: Up to 8 hours
Percentage (%) of total 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)
Time Frame: Up to 8 hours
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.
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)
Time Frame: 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
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)
Time Frame: 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. 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.
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)
Time Frame: Up to 8 hours
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)
Up to 8 hours
AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.7)
Time Frame: Up to 8 hours
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.
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)
Time Frame: Up to 8 hours
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)
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)
Time Frame: Up to 8 hours
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.
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)
Time Frame: Up to 8 hours
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
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)
Time Frame: Up to 8 hours
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
Up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andrew Tomas Reisner

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nihon Kohden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew T Reisner, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P000837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD may be shared if consistent with our institutional policy and approved by Nihon Kohden Innovation Center

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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