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临床试验/NCT04713605
NCT04713605招募中不适用

Cerebral Blood Flow in Neonates During Major Cardiac- and Non-cardiac Surgery

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
80
试验地点
1
主要终点
Critical Closing Pressure (CrCP)

研究概览

简要总结

Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. For CBF, the systemic blood pressure should be managed above the brain's critical closing pressure (CrCP), and preferably above the lower limit of autoregulation (LLA), if intact.

Objective: The investigators aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and neurobehavioral outcomes.

Study design: In a prospective observational cohort study bilateral cerebral blood flow velocity (CBFV) measurements are performed with transcranial doppler (TCD), together with invasive arterial blood pressure (iABP) measurements in the perioperative period.

Study population: Neonates (semi-) electively scheduled for major cardiac- and non cardiac surgery.

Main study parameters/endpoints: Main study endpoint is the Critical Closing Pressure (CrCP) within and between subjects. Furthermore, we evaluate the association with new white matter injury (WMI) on the postoperative MRI.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Anticipated risks caused by TCD monitoring in neonates are considered negligible when monitoring is executed according to the BMUS guidelines and ALARA principle. Each time energy is converted from one form to another, part of it is inevitably converted to heat. Theoretically, if at all, the maximum temperature rise will happen at the skin- temporal bone side, where the monitoring probes are placed. A maximal thermal index (TI) of 0.7 is allowed, this corresponds with 0.7 o C temperature rise.

Patients might not benefit from participation in this study as the TCD measurements are only visible and available to the TCD operator, and we do not yet know how the results could possibly influence the procedure. However, in the unlikely situation where cerebral perfusion is severely compromised for a longer period of time or in case of occurrence of large air emboli, improper cannulation or cross clamping the cardiac team will be notified. Therefore, a neonate might benefit from participation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Term infant aged < 42 days / Preterm born > 32 weeks and with a corrected age < 42 days
  • (Semi-) elective cardiac of major non-cardiac surgery
  • Routine placement of an arterial cannula for invasive blood pressure monitoring.

排除标准

  • Grade III-IV intracranial hemorrhage.
  • Emergency surgery or semi-elective surgery performed out of hours.
  • Informed consent from the parents is not obtained.

结局指标

主要结局

Critical Closing Pressure (CrCP)

时间窗: During congenital heart surgery

Detection of the critical closing pressure (CrCP) of the brain, the arterial blood pressure at which brain vessels collapse and cerebral blood flow ceases, in a cohort of neonates who need major cardiac surgery. We hypothesize that neonates have a unique CrCP and cerebral ischemia occurs during episodes with critically endangered blood supply to the brain, when the arterial blood pressure (iABP) is below CrCP.

次要结局

  • Incidence white matter injury (WMI) on the postoperative MRI.(Within the first postoperative 10 days)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kim van Loon

Principle investigator

UMC Utrecht

研究点 (1)

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