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临床试验/NCT03222414
NCT03222414终止不适用

Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient (BMI >= 40 kg/m2) With Severe Preeclampsia: A Comparison of Direct Arterial Blood Pressure Measurements With Readings Obtained Using Either Large Cylindrical or Novel Conical Bariatric Upper Arm Blood Pressure Cuffs

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement

研究概览

简要总结

The study will compare agreement of invasive blood pressure measurements with non-invasive blood pressure measurements measured with a conical blood pressure and large standard upper arm rectangular cuff in morbidly obese severely hypertensive (systolic blood pressure > 160 mmHg) parturients.

详细描述

A morbidly obese [Body Mass Index (BMI) ≥ 40 kg/m2] pregnant woman is at singular risk for all the complications of pregnancy, most notably preeclampsia (PE). Furthermore a woman who is already chronically hypertensive is likely to develop superimposed PE . Uncontrolled systolic hypertension in pregnancy prompts placental abruption, hemorrhagic stroke, and systolic or diastolic heart failure. Accurate blood pressure measurement is therefore a prerequisite to controlling dangerously high systolic blood pressure (SBP) to enable labor and delivery to be conducted safely in association with PE. Precise SBP measurement is also a precondition for clinically testing hypotheses concerning the existence of druggable targets that will allow prolongation of pregnancy in the face of severe PE and /or intra-uterine growth restriction (IUGR) remote from term.

Oscillometric noninvasive blood pressure (NIBP) measurement is the customary standard blood pressure monitoring method most often used in the labor suite and obstetric operating room today. For this purpose a rectangular, cylindrical blood pressure (BP) cuff placed on the upper arm is connected to an oscillometric blood pressure device. Yet inaccuracies related to the fact that oscillometric NIBP devices under-read high SBP relative to IBP measurements have been recognized as a potential source of maternal morbidity for years.

The study will compare IBP readings obtained from morbidly obese, severely hypertensive (SBP > 160 mm Hg) parturients with NIBP consecutively measured with new innovative conical Ultracheck Curve BP cuffs and large standard upper arm rectangular cylindrical BP cuffs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

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

  • Written, signed and dated informed consent
  • ≥ 18 years of age
  • BMI >40 kg/m2
  • Has a clinically indicated radial artery line already in situ or who agree to placement of an arterial line
  • Systolic blood pressure >160 mm Hg
  • Gestational age greater than or equal to 24 weeks
  • Parturients admitted for induction of labor

排除标准

  • Parturients admitted in labor

结局指标

主要结局

Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement

时间窗: Single time point measurement (1 day)

Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings

次要结局

  • Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring(Single time point measurement (1 day))
  • Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement(Single time point measurement (1 day))
  • Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs(Single time point measurement (1 day))
  • Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs(Single time point measurement (1 day))
  • Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs(Single time point measurement (1 day))

研究者

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

Laura Sorabella

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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