A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty

Recruiting

• Conditions: Cranial Defect; TCD

• Registration Number: NCT06642532
• Lead Sponsor: RenJi Hospital

Brief Summary

Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-13
• Study First Submitted QC: 2024-10-13
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age of 18 years or older;
2. Proposed polyetheretherketone cranioplasty;
3. Incomplete cranial bone in the lateral temporal window;
4. Signed informed consent for surgery and informed consent for research.

Exclusion Criteria

1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
transcranial doppler ultrasonography parameters before and after cranioplasty	6 months	transcranial doppler ultrasonography's hemodynamic parameters: Pulse Index（PI） of middle cerebral artery(MCA), terminal internal carotid artery(TICA), anterior communicating artery(ACA), and posterior cerebral artery(PCA) from bilateral temporal window before and after polyetheretherketone cranioplasty. PI=（Vs - Vd ）/ Vm。

Trial Locations

Locations (2)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China