Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583163
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

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
Cerebral Aneurysm Stroke Vasospasm, Cerebral Subarachnoid Hemorrhage, Aneurysmal Aneurysmal Subarachnoid Hemorrhage Cerebral Ischemia 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

Layout table for study information
Study Type : Observational
Estimated 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 : September 22, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Neuro-critical care patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583163


Contacts
Layout table for location contacts
Contact: Melissa Blatt, MSN 551-996-2000 Melissa.Blatt@hmhn.org
Contact: Tania Zielonka, CCRP 551-996-2000 ext 4452 tania.zielonka@hmhn.org

Locations
Layout table for location information
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Melissa Blatt, MSN    551-996-2000    melissa.blatt@hmhn.org   
Contact: Tania Zielonka, CCRP    551-996-2000 ext 4452    tania.zielonka@hmhn.org   
Principal Investigator: Stephen M Cohn, MD FACS         
Sub-Investigator: Jyoti Sharma, MD FACS         
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
Layout table for investigator information
Principal Investigator: Stephen M Cohn, MD FACS Hackensack Meridian Health
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04583163    
Other Study ID Numbers: 2019-0945
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Transcranial Doppler
TCD
Interrater Variability
Intrarater Variability
Transcranial Doppler Ultrasound
Neurocritical Care
DCI
Delayed Cerebral Ischemia
MCA
PCA
Mean Flow Velocity
Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Brain Ischemia
Cerebral Infarction
Intracranial Aneurysm
Vasospasm, Intracranial
Aneurysm
Hemorrhage
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Stroke
Infarction
Necrosis
Intracranial Arterial Diseases