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A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Led by RenJi Hospital · Updated on 2024-11-15
10
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the use of polyetheretherketone (PEEK) material in cranioplasty surgery to assess cerebral blood flow using transcranial doppler ultrasound. This prospective observational study focuses on patients with cranial defects treated with PEEK cranioplasty. It aims to evaluate brain tissue and ventricular morphology through ultrasound imaging performed before and after surgery to better understand cerebral hemodynamic changes. Participants undergo transcranial doppler ultrasound examinations preoperatively and again 10 days postoperatively. The study collects data on bilateral hemodynamic parameters from arteries including the middle cerebral artery (MCA), terminal internal carotid artery (TICA), anterior communicating artery (ACA), and posterior cerebral artery (PCA). Parameters such as peak systolic velocity (Vs), end-diastolic velocity (Vd), mean velocity (Vm), pulsatility index (PI), and resistive index (RI) are recorded from the temporal window. During the study, participants will have ultrasound assessments to monitor cerebral blood flow changes related to the cranioplasty. The primary outcome measure is the transcranial doppler ultrasound parameters before and after the surgery, tracked over a 6-month period. This observational approach helps understand the effects of PEEK cranioplasty on brain hemodynamics without altering standard patient care.
CONDITIONS
Brief Title
A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Proposed polyetheretherketone cranioplasty
- Incomplete cranial bone in the lateral temporal window
- Signed informed consent for surgery and informed consent for research
You will not qualify if you...
- Cranial bone in the temporal region is intact despite proposed cranioplasty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo polyetheretherketone cranioplasty and have transcranial doppler ultrasound examinations to assess cerebral blood flow.
Ultrasound assessments before and after cranioplasty
Trial Site Locations
Total: 2 locations
1
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
2
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Junfeng Feng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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