Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

November 8, 2021 updated by: Hackensack Meridian Health

Inter- and Intra-Observer Variability in Transcranial Doppler (TCD) Technique in Neurocritical Care Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen M Cohn, MD FACS
        • Sub-Investigator:
          • Jyoti Sharma, MD FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neuro-critical care patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the inter- and intra-variability of TCD ultrasound in neuro-critical care patients
Time Frame: 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
Three different TCD technicians will do triplicate readings on 3 consecutive days on patients already undergoing TCD as ordered by their treating team

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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