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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03222414

Enrollment

Registered

2017-07-19

Start date

2015-05-01

Completion date

2016-01-18

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Morbid Obesity, Parturient, Pre-Eclampsia

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.

Interventions

DEVICENon-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

DEVICENon-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

OTHERDirect invasive arterial pressure

Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Participant flow

Pre-assignment details

3 participants were randomized, but data was not analyzable on 2 participants. Randomization assignment was not recorded on these 2 participants.

Participants by arm

Arm	Count
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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements	0
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 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 Direct invasive arterial pressure: Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements	1
Total	1

Baseline characteristics

Characteristic	Arm B: Cylindrical Then Conical	Total	Arm A: Conical Then Cylindrical
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants	0 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	1 participants	1 participants	—
Sex: Female, Male Female	1 Participants	1 Participants	0 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 1
other Total, other adverse events	0 / 0	0 / 1
serious Total, serious adverse events	0 / 0	0 / 1

Outcome results

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