Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06253780
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-30
Brief Title:
Multidisciplinary Study to Verify Blood Pressure Documentation and Response to Titration of Intravenous Medications
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Multidisciplinary Study to Verify Blood Pressure Documentation and Response to Titration of Intravenous Medications
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERBATIM
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None