Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Conditions

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

Keywords

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

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

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Interventions

DIAGNOSTIC_TESTTranscranial 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Determine the Intra-variability of TCD Ultrasound - Depth Measurment	3 Consecutive Days	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.
Determine the Inter-variability of TCD Ultrasound - Depth Measurement	3 consecutive days	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.
Determine the Intra-variability of TCD Ultrasound - EDV Measurement	3 Consecutive Days	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.
Determine the Intra-variability of TCD Ultrasound - PFV Measurement	3 Consecutive Days	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.
Determine the Inter-variability of TCD Ultrasound - EDV Measurement	3 consecutive days	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.
Determine the Inter-variability of TCD Ultrasound - PFV Measurement	3 consecutive days	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.

Secondary

Measure	Time frame	Description
Change in Velocity Prompting Clinical Intervention	3 Consecutive Days	Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients.

Other

Measure	Time frame	Description
Summary Statistics for Depth	Across three visits (during 3 consecutive days)	The statistics are based on 27 measurements from those 3 subjects (27 values = 3 subjects \* 3 visits on 3 consecutive days \* 3 technicians)
Summary Statistics for Each Measurement	Across three visits (during 3 consecutive days)	For each Measurement in the following table, the statistics are based on 27 measurements from those 3 subjects (27 values = 3 subjects \* 3 visits on 3 consecutive days \* 3 technicians)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Neuro-critical Care Patients Receiving Transcranial Doppler Imaging Neuro-critical care patients receiving Transcranial Doppler Imaging in the neurocritical care unit.	3
Total	3

Baseline characteristics

Characteristic	Neuro-critical Care Patients Receiving Transcranial Doppler Imaging
Age, Continuous	51.7 years
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	2 Participants
Region of Enrollment United States	3 participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 3
other Total, other adverse events	0 / 3
serious Total, serious adverse events	0 / 3

Outcome results

Primary

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.

Time frame: 3 consecutive days