Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04583163
Collaborator
(none)
12
1
39.3
0.3

Study Details

Study Description

Brief Summary

This study aims to determine the inter- and intra-variability of Transcranial Doppler (TCD) ultrasound in neuro-critical care patients who are planned for consecutive daily TCD evaluations.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transcranial Doppler

Detailed Description

Patients enrolled in the study are recruited from the pool of neuro-critical care patients admitted to the surgical intensive care unit (SICU). When the patients are admitted in the surgical ICU, the study staff will determine eligibility based on the protocol inclusion criteria. Due to the nature of the disease, there is a high likelihood that patients are either unconscious, of limited mental capacity and/or have been intubated therefore when appropriate the legally authorized representative will be utilized to obtain research consent.

To meet study inclusion, transcranial Doppler (TCD) testing will be ordered as part of the standard of care for these patients. The test will not be ordered solely for research purposes. There are no known side effects from the non-invasive measurement of cerebral blood flow using ultrasound

Three different TCD technicians will do triplicate readings on 3 consecutive days on up to 12 patients already undergoing TCD as ordered by their treating team. Standard of care on specific neuro critical care patients (such as cerebral aneurysms) is to undergo daily TCD monitoring to assess for possible vasospasm. Patients will be in the supine position while measurements are obtained. The probe will be placed in the preauricular region of the temporal window

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inter- and Intra-Observer Variability in Transcranial Doppler (TCD) Technique in Neurocritical Care Patients
Actual Study Start Date :
Sep 22, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Neuro-critical Care Patients

Up to 12 subjects will be recruited over a 1 year period. Patients enrolled in the study are recruited from the pool of neuro-critical care patients admitted to the surgical intensive care unit (SICU). To meet study inclusion, transcranial Doppler (TCD) testing will be ordered as part of the standard of care for these patients. The test will not be ordered solely for research purposes. There are no known side effects from the non-invasive measurement of cerebral blood flow using ultrasound. Three different TCD technicians will perform triplicate readings on 3 consecutive days on up to 12 patients already undergoing TCD as ordered by their treating team. Standard of care on specific neuro critical care patients (such as cerebral aneurysms) is to undergo daily TCD monitoring to assess for possible vasospasm. Patients will be in the supine position while measurements are obtained. The probe will be placed in the preauricular region of the temporal window.

Diagnostic Test: Transcranial Doppler
Transcranial Doppler is a non-invasive, painless, ultrasound technique that uses high frequency sound waves to measure the rate and direction of blood flow vessels in the brain.
Other Names:
  • TCD
  • TCD Ultrasound
  • Transcranial Doppler Ultrasound
  • Transcranial Neurovascular Exam
  • TCD Study
  • Transcranial Doppler Study
  • Outcome Measures

    Primary Outcome Measures

    1. Determine the inter- and intra-variability of TCD ultrasound in neuro-critical care patients [Three different TCD technicians will do triplicate readings on 3 consecutive days on patients already undergoing TCD as ordered by their treating team]

      This study aims to determine the inter- and intra-variability of Transcranial Doppler (TCD) ultrasound in 12 neuro- critical care patients who are planned for daily TCD evaluation. Up to 12 subjects will be recruited over a 1 year period. Patients enrolled in the study are recruited from the pool of neuro-critical care patients admitted to the surgical intensive care unit (SICU). The study aims to determine the inter- and intra-variability of TCD ultrasound in neuro critical care patients who are planned for daily TCD evaluation. The following measurements will be assessed: The peak and mean flow velocity of the middle cerebral artery (MCA) The peak and mean flow velocity of the posterior cerebral artery (PCA) The peak and mean flow velocity of the basilar arteries

    Secondary Outcome Measures

    1. Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients [Data will be assessed from TCD readings performed on triplicate readings on 3 consecutive days on patients already undergoing TCD as ordered by their treating team]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Adults 18 years of age or older

    2. Current hospitalization for a neurologic issue and admitted to the surgical intensive care unit.

    3. Undergoing daily transcranial Doppler imaging No

    4. English speaking patients and/or legally authorized representative (LAR)

    Exclusion Criteria:
    1. Less than 18 years of age

    2. Patient is unable to obtain consent and no LAR is identified to provide consent

    3. Non-English speaking patient or LAR

    4. Unable to perform the study due to lack of availability of TCD technologists

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health

    Investigators

    • Principal Investigator: Stephen M Cohn, MD FACS, Hackensack Meridian Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT04583163
    Other Study ID Numbers:
    • 2019-0945
    First Posted:
    Oct 12, 2020
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hackensack Meridian Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021