BP Management System User Acceptance Testing

NCT ID: NCT04688450

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2023-05-31

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.

Conditions

Hypotension and Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intervention group

The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects

Group Type: EXPERIMENTAL

VIGORIS Blood Pressure Management Clinical Decision Support System

Intervention Type: DEVICE

Software system to optimize tight blood pressure management during vasopressor infusion

Interventions

VIGORIS Blood Pressure Management Clinical Decision Support System

Software system to optimize tight blood pressure management during vasopressor infusion

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon Kohden

INDUSTRY

Sponsor Role: collaborator

Andrew Tomas Reisner

OTHER

Sponsor Role: lead

Responsible Party

Andrew Tomas Reisner

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew T Reisner, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019P000837

Identifier Type: -

Identifier Source: org_study_id