Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia
NCT ID: NCT03222414
Last Updated: 2019-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2015-05-01
2016-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
18 Years
FEMALE
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Laura Sorabella
Assistant Professor
Principal Investigators
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Laura Sorabella, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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150606
Identifier Type: -
Identifier Source: org_study_id