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

Primary Purpose

Pre-Eclampsia, Morbid Obesity, Parturient

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive BP recording with conical Ultracheck Curve BP cuff
Non-invasive BP recording with traditional cylindrical BP cuff
Direct invasive arterial pressure
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pre-Eclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Conical then Cylindrical

Arm B: Cylindrical then Conical

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
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
Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs

Full Information

First Posted
July 17, 2017
Last Updated
December 10, 2019
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03222414
Brief Title
Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Changes in standard of care have altered the feasibility of the study.
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
January 18, 2016 (Actual)
Study Completion Date
January 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Morbid Obesity, Parturient, Blood Pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Conical then Cylindrical
Arm Type
Experimental
Arm Description
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 Title
Arm B: Cylindrical then Conical
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Non-invasive BP recording with conical Ultracheck Curve BP cuff
Intervention Description
Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff
Intervention Type
Device
Intervention Name(s)
Non-invasive BP recording with traditional cylindrical BP cuff
Intervention Description
Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff
Intervention Type
Other
Intervention Name(s)
Direct invasive arterial pressure
Intervention Description
Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements
Primary Outcome Measure Information:
Title
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Description
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)
Secondary Outcome Measure Information:
Title
Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
Description
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)
Title
Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Description
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)
Title
Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
Description
mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs
Time Frame
Single time point measurement (1 day)
Title
Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
Description
Mean of 2 MAP readings taken with cylindrical and conical BP cuffs
Time Frame
Single time point measurement (1 day)
Title
Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Sorabella, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32748394
Citation
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.
Results Reference
derived

Learn more about this trial

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

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