Clinical trial NCT04688450: BP Management System User Acceptance Testing
Official title: Live User Acceptance Testing of a Decision Support System to Optimize Blood Pressure Management During Critical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension and Shock
Keywords: vasopressor
arterial blood pressure
clinical decision support system
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Nihon Kohden
First posted: 2020-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm feasibility study
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative Nurse-subject Survey Response
timeFrame: Up to 8 hours
measure: Software Operation (Based on Real-time Observation)
timeFrame: Up to 8 hours
measure: Data Completeness
timeFrame: Up to 8 hours
measure: Software Operation (Based on Review of Error Logs)
timeFrame: Up to 8 hours
Secondary outcomes:
measure: Percentage of Time That the BP Forecast is Operative (Outcome 2.1)
timeFrame: up to 8 hours
measure: Accuracy of the MAP Forecast (Outcome 2.2)
timeFrame: Up to 8 hours
measure: Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3)
timeFrame: Up to 8 hours
measure: SHE Incidence (Outcome 3.1)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1)
timeFrame: Up to 8 hours
measure: Advance Warning Times (AWTs) for SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.2)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.3)
timeFrame: Up to 8 hours
measure: AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.4)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.1)
timeFrame: Up to 8 hours
measure: AWTs for SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.2)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.3)
timeFrame: Up to 8 hours
measure: AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.4)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Detected by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.1)
timeFrame: Up to 8 hours
measure: AWTs for SHEs Predicted by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.2)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs Detected by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.3)
timeFrame: Up to 8 hours
measure: AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.4)
timeFrame: Up to 8 hours
measure: Percentage of Total SHEs With False Resolutions (Outcome 3.5.1)
timeFrame: Up to 8 hours
measure: Percentage of Total SHE False Resolutions Detected by {Index > 35%} (Outcome 3.5.2)
timeFrame: Up to 8 hours
measure: Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} With InOp State During False Resolution (Outcome 3.5.3)
timeFrame: Up to 8 hours
measure: Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} Without InOp State During False Resolution (Outcome 3.5.4)
timeFrame: Up to 8 hours
measure: Percentage of Total SHE False Resolutions Detected by {Index > User's Index Threshold Setting} (Outcome 3.5.5)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} That Are Contiguous With SHEs (Outcome 3.6.1)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Contiguous With SHEs (Outcome 3.6.2)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} That Are Sentinel Notifications (Outcome 3.6.3)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Sentinel Notifications (Outcome 3.6.4)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} That Are False Notifications (Outcome 3.6.5)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} That Are False Notifications (Outcome 3.6.6)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} Contiguous With an SHE False Resolution (Outcome 3.6.7)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE False Resolution (Outcome 3.6.8)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.9)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.10)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.11)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.12)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > 35%} With Onset During an SHE (Outcome 3.6.13)
timeFrame: Up to 8 hours
measure: Incidence of Notification Events {Index > User's Index Threshold Setting} With Onset During an SHE (Outcome 3.6.14)
timeFrame: Up to 8 hours
measure: Duration of False Notification Events {Index > 35%} (Outcome 3.6.15)
timeFrame: Up to 8 hours
measure: Duration of False Notification Events {Index > User's Index Threshold Setting} (Outcome 3.6.16)
timeFrame: Up to 8 hours
measure: Stuttering Hypotension Incidence (Outcome 3.7.1)
timeFrame: Up to 8 hours
measure: Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.2)
timeFrame: Up to 8 hours
measure: AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.3)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
measure: Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.6)
timeFrame: Up to 8 hours
measure: AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.7)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
measure: AWTs for Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.9)
timeFrame: Up to 8 hours
measure: Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.10)
timeFrame: Up to 8 hours
measure: 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)
timeFrame: Up to 8 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew T Reisner, MD
role: PRINCIPAL_INVESTIGATOR
References: