Status:
COMPLETED
BP Management System User Acceptance Testing
Lead Sponsor:
Andrew Tomas Reisner
Collaborating Sponsors:
Nihon Kohden
Conditions:
Hypotension and Shock
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04688450
Start Date
January 21 2021
End Date
May 31 2023
Last Update
January 27 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114