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

NCT06253780 | Completed

• 1 other identifier: 3034
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

neurovascular illness; Neurocritical care; Blood pressure; Continuous data acquisition; Neurology; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Cohort 1

Adult patients (age \> 18 years old) admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible receiving Intravenous vasoactive medication infusing at the time of consent.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study personnel will identify NSICU patients who are receiving an IV vasoactive medication infusion and are scheduled to have an arterial line (A-line) placed, or already have an A-line placed. This information is found in the EMR. Following consent, the study team will assign each patient a subject identification number (SID) that will be used as an alternate to any protected health information (PHI). After consent has been given, the study team will coordinate a time to place the CNS-200 monitor in the room of the patient. In the NSICU, the SOC is to routinely test BP using a cuff and or A-line.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Chiesi USA, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• DaiWai M Olson, PhD, RN, FNCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 12, 2024
• Study Start: January 12, 2024
• Primary Completion: May 1, 2024
• Study Completion: January 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

US (1)