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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff
Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff
Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings
Time frame: Single time point measurement (1 day)
Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings
Time frame: Single time point measurement (1 day)
Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings
Time frame: Single time point measurement (1 day)
Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs
Time frame: Single time point measurement (1 day)
Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
Mean of 2 MAP readings taken with cylindrical and conical BP cuffs
Time frame: Single time point measurement (1 day)
Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs
Time frame: Single time point measurement (1 day)
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Enrollment
3