BP Management System User Acceptance Testing

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04688450
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 21, 2021
Completion date	December 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.