Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

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Brief Title

Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Official Title

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

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.
    

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


Primary Outcome

Determine the inter- and intra-variability of TCD ultrasound in neuro-critical care patients

Secondary Outcome

 Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients

Condition

Cerebral Aneurysm

Intervention

Transcranial Doppler

Study Arms / Comparison Groups

 Neuro-critical Care Patients
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

12

Start Date

September 22, 2020

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A


Contacts

Stephen M Cohn, MD FACS, 551-996-2000, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04583163

Organization ID

2019-0945


Responsible Party

Sponsor

Study Sponsor

Hackensack Meridian Health


Study Sponsor

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


Verification Date

October 2020