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临床试验/NCT03867461
NCT03867461已完成不适用

Prospective Measurement of Blood Pressure and End Tidal Carbon Dioxide Content Effects on Venous Sinus Caliber and Pressures in Patients With Idiopathic Intracranial Hypertension Undergoing Stenting

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Venous Sinus Pressures

研究概览

简要总结

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

详细描述

To prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. Venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Adults determined to be candidates for venous sinus stenting

排除标准

  • 未提供

研究组 & 干预措施

Group A

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg.

干预措施: Venous Sinus Stenting (Procedure)

Group A

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg.

干预措施: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) (Other)

Group A

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg.

干预措施: Adjustment to Mean Arterial Pressure (100-110 mmHg range) (Other)

Group B

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Venous Sinus Stenting (Procedure)

Group B

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) (Other)

Group B

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Adjustment to Mean Arterial Pressure (60-80 mmHg range) (Other)

Group C

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Venous Sinus Stenting (Procedure)

Group C

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) (Other)

Group C

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg,

干预措施: Adjustment to Mean Arterial Pressure (100-110 mmHg range) (Other)

Group D

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg,

干预措施: Venous Sinus Stenting (Procedure)

Group D

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg,

干预措施: Adjustment to Mean Arterial Pressure (100-110 mmHg range) (Other)

Group D

Active Comparator

Adult patients determined to be candidates for venous sinus stenting.

End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:

For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg,

干预措施: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range) (Other)

结局指标

主要结局

Venous Sinus Pressures

时间窗: After intervention, up to 5 minutes

Venous Sinus Pressures

时间窗: Baseline

次要结局

  • Venous Sinus Diameter(After Intervention, up to 5 minutes)
  • Venous Sinus Diameter(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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