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

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

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.

Study Overview

• Status: Terminated
• Conditions: Blood Pressure; Morbid Obesity; Pre-Eclampsia; Parturient
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Exclusion Criteria:

• Parturients admitted in labor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Conical then Cylindrical; 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	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff; Device: Non-invasive BP recording with traditional cylindrical BP cuff; Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff; Other: Direct invasive arterial pressure; Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements
Active Comparator: Arm B: Cylindrical then Conical; 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	Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff; Device: Non-invasive BP recording with traditional cylindrical BP cuff; Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff; Other: Direct invasive arterial pressure; Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Single time point measurement (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	Single time point measurement (1 day)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Laura Sorabella, M.D., Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): January 18, 2016
• Study Completion (Actual): January 18, 2016

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Hypertension, Pregnancy-Induced; Obesity; Obesity, Morbid; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 150606 (Registry Identifier: Program for preterm infants)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No