Automated Robotic TCD in Traumatic Brain Injury

Recruiting

• Conditions: Brain Injuries, Traumatic
• Interventions: Device: Transcranial Doppler ultrasonography (TCD)

• Registration Number: NCT05848297
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience

Detailed Description

Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.

Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for \>= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period

Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Study Start: 2025-06-30
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults ≥18
• Blunt TBI with Glasgow Coma Score (GCS) ≤8
• Injury within 72 hours
• Adequate TCD windows
• Ability to obtain informed consent from a Legally Authorized Representative (LAR)

Exclusion Criteria

• Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
• C- spine fracture with evidence of spinal cord injury
• Severe skull or scalp injury precluding device placement
• Planned decompressive hemicraniectomy
• Continuous fever for >6 hours at the time of enrollment (despite treatment)
• Lack of TCD window

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prolonged automated TCD	Transcranial Doppler ultrasonography (TCD)	-

Primary Outcome Measures

Name	Time	Method
Patient discomfort (per discretion of the bedside nurse)	2 years	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe
Inadvertent dislodgement of other intracranial monitoring device/s (if present)	2 years	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Skin changes associated with TCD	2 years	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.	2 years	A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety of protocol implementation.
Evaluation of adequate temporal windows	2 years	To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Evaluation of adequate insolation of middle cerebral arteries (MCA)	2 years	To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population	2 years	A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.

Trial Locations

Locations (3)

University of California, Davis; 🇺🇸 Davis, California, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States