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

NCT ID: NCT06642532

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Cranial Defect TCD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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TCD group

Transcranial Doppler ultrasound to examine 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junfeng Feng

Chief Director of Brain Injury Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junfeng Feng

Role: CONTACT

13611860825

Facility Contacts

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Junfeng Feng, MD, PhD

Role: primary

86-21-68383707

Yanqing Ni, MD

Role: backup

86-21-68383707

Qing Mao, MD, PhD

Role: backup

Junfeng Feng, MD, PhD

Role: backup

Ru Gong, MD

Role: backup

Jiyuan Hui, MD

Role: backup

Ke Cao, MD

Role: backup

Junfeng Feng

Role: primary

+8613611860825

Other Identifiers

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LY2024-093-B

Identifier Type: -

Identifier Source: org_study_id

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