BP Management System User Acceptance Testing

NCT04688450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-27

Study results available
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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

Interventions

DEVICE

VIGORIS Blood Pressure Management Clinical Decision Support System

Software system to optimize tight blood pressure management during vasopressor infusion

Sponsors & Collaborators

  • Nihon Kohden

    collaborator INDUSTRY
  • Andrew Tomas Reisner

    lead OTHER

Principal Investigators

  • Andrew T Reisner, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2022-05-31
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688450 on ClinicalTrials.gov