Trial Outcomes & Findings for Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients (NCT NCT04583163)

NCT ID: NCT04583163

Last Updated: 2025-04-15

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 3 participants
• Primary outcome timeframe: 3 consecutive days
• Results posted on: 2025-04-15

Participant Flow

Participant milestones

Measure	Neuro-critical Care Patients Receiving Transcranial Doppler Imaging Neuro-critical care patients admitted to the surgical intensive care unit (SICU) receiving Transcranial Doppler Imaging
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Baseline characteristics by cohort

Measure	Neuro-critical Care Patients Receiving Transcranial Doppler Imaging n=3 Participants Neuro-critical care patients receiving Transcranial Doppler Imaging in the neurocritical care unit.
Age, Continuous	51.7 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 consecutive days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Inter-variability of TCD Ultrasound - EDV Measurement End Diastolic Velocity (EDV) Visit 1	0.986 intraclass correlation coefficient (ICC) Interval 0.874 to 1.0	—	—
Determine the Inter-variability of TCD Ultrasound - EDV Measurement EDV Visit 2	0.960 intraclass correlation coefficient (ICC) Interval 0.715 to 0.999	—	—
Determine the Inter-variability of TCD Ultrasound - EDV Measurement EDV Visit 3	0.817 intraclass correlation coefficient (ICC) Interval 0.26 to 0.995	—	—

PRIMARY outcome

Timeframe: 3 consecutive days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Readings There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Inter-variability of TCD Ultrasound - PFV Measurement Peak Flow Velocity (PFV) Visit 1	0.974 intraclass correlation coefficient (ICC) Interval 0.809 to 0.999	—	—
Determine the Inter-variability of TCD Ultrasound - PFV Measurement PFV Visit 2	0.973 intraclass correlation coefficient (ICC) Interval 0.792 to 0.999	—	—
Determine the Inter-variability of TCD Ultrasound - PFV Measurement PFV Visit 3	0.918 intraclass correlation coefficient (ICC) Interval 0.558 to 0.998	—	—

PRIMARY outcome

Timeframe: 3 consecutive days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Inter-variability of TCD Ultrasound - Depth Measurement Depth Visit 1	0.938 intraclass correlation coefficient (ICC) Interval 0.874 to 1.0	—	—
Determine the Inter-variability of TCD Ultrasound - Depth Measurement Depth Visit 2	0.013 intraclass correlation coefficient (ICC) Interval -0.426 to 0.93	—	—
Determine the Inter-variability of TCD Ultrasound - Depth Measurement Depth Visit 3	0.904 intraclass correlation coefficient (ICC) Interval 0.463 to 0.997	—	—

PRIMARY outcome

Timeframe: 3 Consecutive Days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Intra-variability of TCD Ultrasound - EDV Measurement End Diastolic Velocity (EDV) by Technician A	0.979 intraclass correlation coefficient (ICC) Interval 0.773 to 0.999	—	—
Determine the Intra-variability of TCD Ultrasound - EDV Measurement EDV by Technician B	0.989 intraclass correlation coefficient (ICC) Interval 0.88 to 1.0	—	—
Determine the Intra-variability of TCD Ultrasound - EDV Measurement EDV by Technician C	0.960 intraclass correlation coefficient (ICC) Interval 0.576 to 0.999	—	—

PRIMARY outcome

Timeframe: 3 Consecutive Days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Intra-variability of TCD Ultrasound - PFV Measurement Peak Flow Velocity (PFV) by Technician A	0.985 intraclass correlation coefficient (ICC) Interval 0.837 to 1.0	—	—
Determine the Intra-variability of TCD Ultrasound - PFV Measurement PFV by Technician B	0.982 intraclass correlation coefficient (ICC) Interval 0.812 to 1.0	—	—
Determine the Intra-variability of TCD Ultrasound - PFV Measurement PFV by Technician C	0.963 intraclass correlation coefficient (ICC) Interval 0.611 to 0.999	—	—

PRIMARY outcome

Timeframe: 3 Consecutive Days

Population: 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.

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.

Outcome measures

Measure	All Participants n=9 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Determine the Intra-variability of TCD Ultrasound - Depth Measurment Depth by Technician A	-4.154 Intraclass Correlation Coefficient Interval -53.884 to 0.869	—	—
Determine the Intra-variability of TCD Ultrasound - Depth Measurment Depth by Technician B	0.219 Intraclass Correlation Coefficient Interval -7.32 to 0.98	—	—
Determine the Intra-variability of TCD Ultrasound - Depth Measurment Depth by Technician C	0.008 Intraclass Correlation Coefficient Interval -9.563 to 0.975	—	—

SECONDARY outcome

Timeframe: 3 Consecutive Days

Population: Number of patients who had clinical interventions based on the change in velocity observed.

Describe the change in velocity that prompts clinical intervention in symptomatic and asymptomatic vasospasm in neuro-critical care patients.

Outcome measures

Measure	All Participants n=3 Participants There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Change in Velocity Prompting Clinical Intervention	0 participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Across three visits (during 3 consecutive days)

Population: Based on 27 measurements from those 3 subjects (27 values = 3 subjects \* 3 visits during 3 consecutive days\* 3 technicians)

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)

Outcome measures

Measure	All Participants n=27 Readings There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) n=27 Readings MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) n=27 Readings PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Summary Statistics for Each Measurement	37.4 cm/sec Standard Deviation 13.7	125.68 cm/sec Standard Deviation 29.77	100.8 cm/sec Standard Deviation 21.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Across three visits (during 3 consecutive days)

Population: Based on 27 measurements from those 3 subjects (27 values = 3 subjects \* 3 visits during 3 consecutive days\* 3 technicians)

The statistics are based on 27 measurements from those 3 subjects (27 values = 3 subjects * 3 visits on 3 consecutive days * 3 technicians)

Outcome measures

Measure	All Participants n=27 Reading There are no groups/arms for the purpose of this study	Mean Flow Velocity (MFV) MFV measured by Transcranial Doppler (TCD) ultrasound. Measured in cm/s.	Peak Flow Velocity (PFV) PFV measured by Transcranial Doppler (TCD) Ultrasound. Measured in cm/s.
Summary Statistics for Depth	6.8 mm Standard Deviation 7.3	—	—

Adverse Events

Neuro-critical Care Patients Receiving Transcranial Doppler Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tania Zielonka

Hackensack Meridian Health

Phone: 5519964452

Email: tania.zielonka@hmhn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place