Clinical trial NCT04583163: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuro-critical 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

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

Primary outcomes:
measure: Determine the Inter-variability of TCD Ultrasound - EDV Measurement
timeFrame: 3 consecutive days
measure: Determine the Inter-variability of TCD Ultrasound - PFV Measurement
timeFrame: 3 consecutive days
measure: Determine the Inter-variability of TCD Ultrasound - Depth Measurement
timeFrame: 3 consecutive days
measure: Determine the Intra-variability of TCD Ultrasound - EDV Measurement
timeFrame: 3 Consecutive Days
measure: Determine the Intra-variability of TCD Ultrasound - PFV Measurement
timeFrame: 3 Consecutive Days
measure: Determine the Intra-variability of TCD Ultrasound - Depth Measurment
timeFrame: 3 Consecutive Days
Secondary outcomes:
measure: Change in Velocity Prompting Clinical Intervention
timeFrame: 3 Consecutive Days
Other outcomes:
measure: Summary Statistics for Each Measurement
timeFrame: Across three visits (during 3 consecutive days)
measure: Summary Statistics for Depth
timeFrame: Across three visits (during 3 consecutive days)
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Stephen M Cohn, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
citation: Oyama K, Criddle L. Vasospasm after aneurysmal subarachnoid hemorrhage. Crit Care Nurse. 2004 Oct;24(5):58-60, 62, 64-7.
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.JNS15428. Epub 2015 Oct 23.
citation: 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.
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 323-4. doi: 10.1227/01.NEU.0000349209.69973.88.
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.
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. doi: 10.1016/0301-5629(90)90080-v.
citation: 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.
citation: 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.
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. doi: 10.1023/a:1009925811965.
citation: 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.