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临床试验/NCT05155852
NCT05155852已完成不适用

NIRS-Based Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women With Postpartum Hypertension

Columbia University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Oxygenated hemoglobin concentration

研究概览

简要总结

The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.

详细描述

Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM.

Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women.

This is a single center feasibility study that will include up to 10 women. Postpartum women admitted to the obstetrics high-risk stepdown unit for management of postpartum hypertension will be eligible for this study. Informed consent will be obtained from participants prior to enrollment in the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who have given birth within the previous 12 weeks
  • Admitted to the high-risk inpatient obstetrics unit for management of hypertension
  • With headache or other neurological symptoms such as vision changes

排除标准

  • Acute ischemic stroke
  • Intracerebral or subarachnoid hemorrhage
  • Eclamptic seizures
  • Any other neurological complication requiring transfer to the neurological intensive care unit or stroke stepdown unit
  • History of Reynaud's syndrome

结局指标

主要结局

Oxygenated hemoglobin concentration

时间窗: Continuously collected for up to 24 hours

The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery. \[Describe how the concentration will be obtained, the range of anticipated concentrations, and how to interpret the concentrations - eg, higher concentrations indicate ...\]

Blood pressure (BP)

时间窗: Continuously collected for up to 24 hours

Continuous non-invasive BP monitoring will be utilized (ClearSight finger cuff system, Edwards LifeSciences).

Deoxygenated hemoglobin concentration

时间窗: Continuously collected for up to 24 hours

The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eliza Miller

Assistant Professor of Neurology in the Division of Stroke and Cerebrovascular Disease

Columbia University

研究点 (1)

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