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Study was terminated due to resource limitations
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Velocity Prompting Clinical Intervention | Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients. | 3 Consecutive Days |
| Measure | Description | Time Frame |
|---|---|---|
| Summary Statistics for Each Measurement | 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) | Across three visits (during 3 consecutive days) |
| Summary Statistics for Depth |
Inclusion Criteria:
Exclusion Criteria:
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Neuro-critical care patients
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Cohn, MD FACS | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2868172 | Background | Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. | |
| 15526491 | Result | Oyama K, Criddle L. Vasospasm after aneurysmal subarachnoid hemorrhage. Crit Care Nurse. 2004 Oct;24(5):58-60, 62, 64-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuro-critical Care Patients Receiving Transcranial Doppler Imaging | Neuro-critical care patients admitted to the surgical intensive care unit (SICU) receiving Transcranial Doppler Imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuro-critical Care Patients Receiving Transcranial Doppler Imaging | Neuro-critical care patients receiving Transcranial Doppler Imaging in the neurocritical care unit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | 3 consecutive days | Reading | Reading |
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuro-critical Care Patients Receiving Transcranial Doppler Imaging | Neuro-critical care patients admitted to the surgical intensive care unit (SICU) receiving Transcranial Doppler Imaging |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tania Zielonka | Hackensack Meridian Health | 5519964452 | tania.zielonka@hmhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2020 | Sep 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D020521 | Stroke |
| D020301 | Vasospasm, Intracranial |
| D013345 | Subarachnoid Hemorrhage |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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|
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 |
The statistics are based on 27 measurements from those 3 subjects (27 values = 3 subjects * 3 visits on 3 consecutive days * 3 technicians) |
| Across three visits (during 3 consecutive days) |
| 26495942 | 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. |
| 27737684 | 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. |
| 19625911 | 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. |
| 18245071 | 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. |
| 2181766 | 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. |
| 7914715 | 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. |
| 1580013 | 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. |
| 12568169 | 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. |
| 18839484 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| All Participants |
There are no groups/arms for the purpose of this study |
|
|
| Primary | 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | 3 consecutive days | Readings | Readings |
|
|
|
| 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | 3 consecutive days | Reading | Reading |
|
|
|
| Primary | 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | 3 Consecutive Days | Reading | Reading |
|
|
|
| Primary | 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | 3 Consecutive Days | Reading | Reading |
|
|
|
| Primary | 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. | Readings from all enrolled participants. Only three patients were enrolled, but each patient was measured by three separate technicians at three different visits, hence the 9 readings (for 3 patients) per visit. | Posted | Number | 95% Confidence Interval | Intraclass Correlation Coefficient | 3 Consecutive Days | Reading | Reading |
|
|
|
| Secondary | Change in Velocity Prompting Clinical Intervention | Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients. | Number of patients who had clinical interventions based on the change in velocity observed. | Posted | Number | participants | 3 Consecutive Days |
|
|
|
| Other Pre-specified | Summary Statistics for Each Measurement | 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) | Based on 27 measurements from those 3 subjects (27 values = 3 subjects * 3 visits during 3 consecutive days* 3 technicians) | Posted | Mean | Standard Deviation | cm/sec | Across three visits (during 3 consecutive days) | Readings | Readings |
|
|
|
| Other Pre-specified | Summary Statistics for Depth | The statistics are based on 27 measurements from those 3 subjects (27 values = 3 subjects * 3 visits on 3 consecutive days * 3 technicians) | Based on 27 measurements from those 3 subjects (27 values = 3 subjects * 3 visits during 3 consecutive days* 3 technicians) | Posted | Mean | Standard Deviation | mm | Across three visits (during 3 consecutive days) | Reading | Reading |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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