Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
NCT ID: NCT04583163
Last Updated: 2025-04-15
Study Results
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View full resultsBasic Information
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TERMINATED
3 participants
OBSERVATIONAL
2020-09-22
2022-08-12
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Stephen M Cohn, MD FACS
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, United States
Countries
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References
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Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Oyama K, Criddle L. Vasospasm after aneurysmal subarachnoid hemorrhage. Crit Care Nurse. 2004 Oct;24(5):58-60, 62, 64-7.
Kumar G, Shahripour RB, Harrigan MR. Vasospasm on transcranial Doppler is predictive of delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurosurg. 2016 May;124(5):1257-64. doi: 10.3171/2015.4.JNS15428. Epub 2015 Oct 23.
Francoeur CL, Mayer SA. Management of delayed cerebral ischemia after subarachnoid hemorrhage. Crit Care. 2016 Oct 14;20(1):277. doi: 10.1186/s13054-016-1447-6.
Carrera E, Schmidt JM, Oddo M, Fernandez L, Claassen J, Seder D, Lee K, Badjatia N, Connolly ES Jr, Mayer SA. Transcranial Doppler for predicting delayed cerebral ischemia after subarachnoid hemorrhage. Neurosurgery. 2009 Aug;65(2):316-23; discussion 323-4. doi: 10.1227/01.NEU.0000349209.69973.88.
Rigamonti A, Ackery A, Baker AJ. Transcranial Doppler monitoring in subarachnoid hemorrhage: a critical tool in critical care. Can J Anaesth. 2008 Feb;55(2):112-23. doi: 10.1007/BF03016323.
Maeda H, Etani H, Handa N, Tagaya M, Oku N, Kim BH, Naka M, Kinoshita N, Nukada T, Fukunaga R, et al. A validation study on the reproducibility of transcranial Doppler velocimetry. Ultrasound Med Biol. 1990;16(1):9-14. doi: 10.1016/0301-5629(90)90080-v.
Baumgartner RW, Mathis J, Sturzenegger M, Mattle HP. A validation study on the intraobserver reproducibility of transcranial color-coded duplex sonography velocity measurements. Ultrasound Med Biol. 1994;20(3):233-7. doi: 10.1016/0301-5629(94)90063-9.
Totaro R, Marini C, Cannarsa C, Prencipe M. Reproducibility of transcranial Dopplersonography: a validation study. Ultrasound Med Biol. 1992;18(2):173-7. doi: 10.1016/0301-5629(92)90128-w.
Shen Q, Stuart J, Venkatesh B, Wallace J, Lipman J. Inter observer variability of the transcranial Doppler ultrasound technique: impact of lack of practice on the accuracy of measurement. J Clin Monit Comput. 1999 May;15(3-4):179-84. doi: 10.1023/a:1009925811965.
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-0945
Identifier Type: -
Identifier Source: org_study_id
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