Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia

Not Applicable

Terminated

• Conditions: Pre-Eclampsia; Blood Pressure; Morbid Obesity; Parturient
• Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Device: Non-invasive BP recording with traditional cylindrical BP cuff; Other: Direct invasive arterial pressure

• Registration Number: NCT03222414
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2016-01-18
• Study Completion: 2016-01-18
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Results First Submitted: 2019-11-20
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Results First Posted: 2019-12-11
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• 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

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Exclusion Criteria

• Parturients admitted in labor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm B: Cylindrical then Conical	Non-invasive BP recording with traditional cylindrical BP cuff	BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring
Arm B: Cylindrical then Conical	Direct invasive arterial pressure	BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring
Arm A: Conical then Cylindrical	Non-invasive BP recording with conical Ultracheck Curve BP cuff	BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring
Arm A: Conical then Cylindrical	Direct invasive arterial pressure	BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring
Arm A: Conical then Cylindrical	Non-invasive BP recording with traditional cylindrical BP cuff	BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring; then with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring
Arm B: Cylindrical then Conical	Non-invasive BP recording with conical Ultracheck Curve BP cuff	BP recording with noninvasive traditional cylindrical BP cuff and direct invasive arterial pressure monitoring; then with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring

Primary Outcome Measures

Name	Time	Method
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement	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

Secondary Outcome Measures

Name	Time	Method
Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring	Single time point measurement (1 day)	Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings
Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement	Single time point measurement (1 day)	Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings
Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs	Single time point measurement (1 day)	mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs
Mean of 2 MAP 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
Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements 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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States