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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03222414
• Other study ID #: 150606
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: January 18, 2016

Study information

• Verified date: December 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 18, 2016
• Est. primary completion date: January 18, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Eclampsia
• Morbid Obesity
• Obesity, Morbid
• Parturient
• Pre-Eclampsia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)