Multidisciplinary Study to Verify Blood Pressure Documentation and Response to Titration of Intravenous Medications

Completed

• Conditions: Blood Pressure

• Registration Number: NCT06253780
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous (IV) vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain continuous data acquisition (CDA). The investigators will explore BP change based on electronic medical record (EMR) vs CNS-200 data. This study will consent and observe 30 Neuroscience Intensive Care Unit subjects using pragmatic sampling. Each subject will be observed one-and-only-one time for a 12-hour period.

Detailed Description

In this study, the investigators seek to explore if patients who receive continuous IV vasoactive medication infusion have a difference in blood pressure (BP) response measured and reported continuously versus intermittently. Adult patients (age \> 18 years old) admitted to the Neuroscience Intensive Care Unit at The University of Texas Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible. Patients must be receiving Intravenous vasoactive medication infusing at the time of consent. Eligible patients must have an indwelling Arterial line as placed as part of standard of care. There are no restrictions on obtaining Non-invasive BP during data collection. Patients, or legally authorized representatives (LARs), must be able to consent themselves in English. Subjects will be excluded if they are: Under the age of 18, pregnant, or they are currently incarcerated. Because the study does not have the availability to develop foreign language consents, subjects (or LARs) who are unable to read and communicate in English will also be excluded. The primary null hypothesis is that continuously acquired data from the arterial line have a similar mean and standard deviation as documented values in the EMR. The first step in examining this hypothesis is a simple paired T-test. An F-test will be used to compare the standard deviations. Rejection of the null will indicate the need for additional models to compare the median, Interquartile range (IQR), minimum and maximum values. The area under the curve will be determined as a function of the time above or below the prescribed BP range and the time spent outside of that range.

Study Timeline

• Study Start: 2024-01-12
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Primary Completion: 2024-05-01
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18 years old or older
• Admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis
• Patients must be receiving Intravenous vasoactive medication infusing at the time of consent
• Eligible patients must have an indwelling A-line as placed as part of standard of care
• Patients, or legally authorized representatives, must be able to consent themselves in English.

Exclusion Criteria

• Under the age of 18
• Pregnant
• Incarcerated upon admission to ICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reported blood pressure reliability	12-hour monitoring session once per enrolled patient (baseline)	This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain Continuous data acquisition (CDA) data. The investigators will explore BP change based on Electronic Medical Record (EMR) vs CNS-200 (CDA) data.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States