Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583163
• Other study ID #: 2019-0945
• Status: Recruiting
• Start date: September 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Hackensack Meridian Health
• Contact: Melissa Blatt, MSN
• Phone: 551-996-2000
• Email: Melissa.Blatt[@]hmhn.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysmal Subarachnoid Hemorrhage
• Brain Ischemia
• Cerebral Aneurysm
• Cerebral Infarction
• Cerebral Ischemia
• Hemorrhage
• Intracranial Aneurysm
• Ischemia
• Stroke
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal
• Vasospasm, Cerebral
• Vasospasm, Intracranial

Intervention

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.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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

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- — View Citation

Francoeur CL, Mayer SA. Management of delayed cerebral ischemia after subarachnoid hemorrhage. Crit Care. 2016 Oct 14;20(1):277. Review. — View Citation

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.JNS15 — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. Review. — View Citation

Totaro R, Marini C, Cannarsa C, Prencipe M. Reproducibility of transcranial Dopplersonography: a validation study. Ultrasound Med Biol. 1992;18(2):173-7. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the inter- and intra-variability of TCD ultrasound in neuro-critical care patients	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	Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients		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