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

Blood Pressure Clinical Trial

— VERBATIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253780
• Other study ID #: 3034
• Status: Recruiting
• Start date: January 12, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: DaiWai M Olson, PhD, RN, FNCS
• Phone: 9196993122
• Email: DaiWai.Olson[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Chiesi USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported blood pressure reliability	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.	12-hour monitoring session once per enrolled patient (baseline)