Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

NCT04583163 | Terminated Results FDA Device

• 1 other identifier: 2019-0945
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transcranial Doppler; TCD; Interrater Variability; Intrarater Variability; Transcranial Doppler Ultrasound; Neurocritical Care; DCI; Delayed Cerebral Ischemia; MCA; PCA; Mean Flow Velocity

Outcome Measures

Primary Outcomes (6)

• Determine the Inter-variability of TCD Ultrasound - EDV Measurement

  The inter-variability (agreement among 3 TCD technicians) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated based on the readings from the same visit of a patient by different technician as the index for the interrater reliability or agreement among the three technicians. Based on the suggestion from Koo and Li (2016), the interpretation of the agreement by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 consecutive days

• Determine the Inter-variability of TCD Ultrasound - PFV Measurement

  The inter-variability (agreement among 3 TCD technicians) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated based on the readings from the same visit of a patient by different technician as the index for the interrater reliability or agreement among the three technicians. Based on the suggestion from Koo and Li (2016), the interpretation of the agreement by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 consecutive days

• Determine the Inter-variability of TCD Ultrasound - Depth Measurement

  The inter-variability (agreement among 3 TCD technicians) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated based on the readings from the same visit of a patient by different technician as the index for the interrater reliability or agreement among the three technicians. Based on the suggestion from Koo and Li (2016), the interpretation of the agreement by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 consecutive days

• Determine the Intra-variability of TCD Ultrasound - EDV Measurement

  The intra-variability (reliability or consistency within each TCD technician) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated for each technician based on the readings from the same patient. Based on the suggestion from Koo and Li (2016), the interpretation of the reliability by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 Consecutive Days

• Determine the Intra-variability of TCD Ultrasound - PFV Measurement

  The intra-variability (reliability or consistency within each TCD technician) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated for each technician based on the readings from the same patient. Based on the suggestion from Koo and Li (2016), the interpretation of the reliability by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 Consecutive Days

• Determine the Intra-variability of TCD Ultrasound - Depth Measurment

  The intra-variability (reliability or consistency within each TCD technician) was measured by using the intraclass correlation coefficient (ICC). Three technicians took measurements from the same patient at three different visits. The ICC is calculated for each technician based on the readings from the same patient. Based on the suggestion from Koo and Li (2016), the interpretation of the reliability by using the ICC is defined as: below 0.50 = poor, 0.50-0.75 = moderate, 0.76-0.90 = good, above 090 = excellent.

  3 Consecutive Days

Secondary Outcomes (1)

• Change in Velocity Prompting Clinical Intervention

  3 Consecutive Days

Other Outcomes (2)

• Summary Statistics for Each Measurement

  Across three visits (during 3 consecutive days)

• Summary Statistics for Depth

  Across three visits (during 3 consecutive days)

Study Arms (1)

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

Interventions

Transcranial Doppler DIAGNOSTIC_TEST

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.

Also known as: TCD, TCD Ultrasound, Transcranial Doppler Ultrasound, Transcranial Neurovascular Exam, TCD Study, Transcranial Doppler Study

Neuro-critical Care Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neuro-critical care patients

You may qualify if:

• Adults 18 years of age or older
• Current hospitalization for a neurologic issue and admitted to the surgical intensive care unit.
• Undergoing daily transcranial Doppler imaging No
• English speaking patients and/or legally authorized representative (LAR)

You may not qualify if:

• Less than 18 years of age
• Patient is unable to obtain consent and no LAR is identified to provide consent
• Non-English speaking patient or LAR
• Unable to perform the study due to lack of availability of TCD technologists

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (11)

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

• Oyama K, Criddle L. Vasospasm after aneurysmal subarachnoid hemorrhage. Crit Care Nurse. 2004 Oct;24(5):58-60, 62, 64-7.

  PMID: 15526491 RESULT

• 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.

  PMID: 26495942 RESULT

• 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.

  PMID: 27737684 RESULT

• 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.

  PMID: 19625911 RESULT

• 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.

  PMID: 18245071 RESULT

• 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.

  PMID: 2181766 RESULT

• 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.

  PMID: 7914715 RESULT

• 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.

  PMID: 1580013 RESULT

• 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.

  PMID: 12568169 RESULT

• 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.

  PMID: 18839484 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm; Stroke; Vasospasm, Intracranial; Subarachnoid Hemorrhage; Brain Ischemia

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Limitations and Caveats

The study was closed before target enrollment was achieved and only three patients were enrolled. No formal analysis was conducted and as a result of the target enrollment not being achieved, no clinical interventions were introduced or changed as a results of these measurements.

Results Point of Contact

• Title: Tania Zielonka
• Organization: Hackensack Meridian Health

tania.zielonka@hmhn.org

5519964452

Study Officials

• Stephen M Cohn, MD FACS

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: September 22, 2020
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Locations

US (1)