BP Management System User Acceptance Testing

NCT04688450 | Completed Results DMC FDA Device

• 1 other identifier: 2019P000837
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension and Shock

Keywords

vasopressor; arterial blood pressure; clinical decision support system

Outcome Measures

Primary Outcomes (4)

• Quantitative Nurse-subject Survey Response

  Nurse-subject quantitative survey response (yes/no) about any confusion or perceived inaccuracies of the system; perceived risk of patient management error; or perceived distraction that impacted care delivery

  Up to 8 hours

• Software Operation (Based on Real-time Observation)

  System malfunction (yes/no) observed in real-time by the Technical Observer

  Up to 8 hours

• Data Completeness

  Completeness (yes/no) of flowsheet (data archive of the investigational System) without any lapses in input data from the bedside monitor during connectivity; and without lapses in associated BP forecasts.

  Up to 8 hours

• Software Operation (Based on Review of Error Logs)

  Error-level and critical-level software errors in the runtime log (yes/no)

  Up to 8 hours

Secondary Outcomes (50)

• Percentage of Time That the BP Forecast is Operative (Outcome 2.1)

  up to 8 hours

• Accuracy of the MAP Forecast (Outcome 2.2)

  Up to 8 hours

• Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3)

  Up to 8 hours

• SHE Incidence (Outcome 3.1)

  Up to 8 hours

• Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1)

  Up to 8 hours

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

VIGORIS Blood Pressure Management Clinical Decision Support System DEVICE

Software system to optimize tight blood pressure management during vasopressor infusion

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Tomas Reisner: lead
• Nihon Kohden: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Andrew Tomas Reisner
• Organization: Massachusetts General Hospital

areisner@mgh.harvard.edu

617-726-2241

Study Officials

• Andrew T Reisner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Model Details: This is a single arm feasibility study

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 30, 2020
• Study Start: January 21, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)