Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Terminated

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

Interventions: Diagnostic Test: Transcranial Doppler

Registration Number: NCT04583163

Lead Sponsor: Hackensack Meridian Health

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuro-critical Care Patients	Transcranial Doppler	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.

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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.