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临床试验/CTRI/2024/05/067981
CTRI/2024/05/067981尚未招募不适用

Cerebrodynamic Changes Following Cranioplasty Using a Point-of-care Ultrasound: A Prospective Observational Study

Postgraduate Institute of Medical Education and Reseach1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To compare the changes in ICP of ipsilateral Middle cerebral artery using Pulsatility

研究概览

简要总结

Decompressive craniectomy (DC) is the third most common neurosurgical procedurefor treating TBI in India.Cranioplasty is one of the common neurosurgical procedures usually performed postdecompressive craniectomy, to protect the underlying cerebral structures. The purpose ofcranioplasty is not only to improve cosmesis but also to prevent neurological deterioration.Post-DC patients with large cranial defects are prone to develop the “syndrome of Trephined”also known as the “Sinking skin flap syndrome” which is manifested as dizziness, headache,seizures, motor deficits and language disturbances. The aimof this prospective, observational study is to compare the changes in ICP (derived

by Pulsatility Index of ipsilateral MCA) before and after cranioplasty using transcranial**ultrasound.

TCCD examinations will be performed before induction using a phased array1-5 MHz probe (GE LOGIQ machine) through the transtemporal window. The transducer probewill be placed over the temporal area just above the zygomatic arch in front of the tragus of theear with the pointer facing medially.Before the examination, TCD will be performed under the same physiologicalconditions including the heart rate, blood pressure, temperature, and hematocrit pre- (beforeinduction) and post-cranioplasty (1 hour after surgery). The Doppler spectrum of all the cerebral**arteries will be obtained by 0 0-degree angle of insonation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • The patients with craniectomy defects
  • Posted for cranioplasty in the age group between 18-65 years will be enrolled in the study.

排除标准

  • Patient refusal • Lumbar drain / CSF drainage before during study period • Sepsis 12 • Known cardiac illness • Poor window • Known case of arteritis and major cerebral vasculature stenosis • Patients with the history of ischemic stroke or transient ischemic attacks.

结局指标

主要结局

To compare the changes in ICP of ipsilateral Middle cerebral artery using Pulsatility

时间窗: one-hour post cranioplasty.

index (PI) before and one hour post cranioplasty

时间窗: one-hour post cranioplasty.

次要结局

  • To compare the changes in anterior, middle, and posterior cerebral artery flow(velocities before and after cranioplasty.)
  • To compare the pulsatility index (PI) on both sides before and after cranioplasty.(one-hour post cranioplasty.)
  • To evaluate the neurological outcome post cranioplasty using Modified Rankin scale at(discharge and GOS-E at 3 months.)
  • To observe the changes in the preoperative symptoms after cranioplasty.(At discharge)

研究者

发起方
Postgraduate Institute of Medical Education and Reseach
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Kiran Jangra

Postgraduate Institute Of Medical Education And Research

研究点 (1)

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