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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222414
Recruitment Status : Terminated (Changes in standard of care have altered the feasibility of the study.)
First Posted : July 19, 2017
Results First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Sorabella, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 19, 2017
Results First Submitted Date  ICMJE November 20, 2019
Results First Posted Date  ICMJE December 11, 2019
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE May 1, 2015
Actual Primary Completion Date January 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Comparison of the agreement of systolic blood pressure measurements using non-invasive blood pressure with cylindrical BP cuff and invasive blood pressure recordings [ Time Frame: Single time point measurement (1 day) ]
    Comparison of the agreement of systolic blood pressure measurements using non-invasive blood pressure with cylindrical BP cuff and invasive blood pressure recordings
  • Comparison of the agreement of systolic blood pressure measurements using non-invasive blood pressure with conical BP cuff and invasive blood pressure recordings [ Time Frame: Single time point measurement (1 day) ]
    Comparison of the agreement of systolic blood pressure measurements using non-invasive blood pressure with conical BP cuff and invasive blood pressure recordings
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Single time point measurement (1 day) ]
    Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Comparison of agreement of mean arterial pressure (MAP) non-invasive levels to invasive blood pressure levels [ Time Frame: Single time point measurement (1 day) ]
    Comparison of agreement of mean arterial pressure (MAP) non-invasive levels to invasive blood pressure levels
  • Comparison of agreement of diastolic blood pressure non-invasive blood pressure recordings to invasive blood pressure levels [ Time Frame: Single time point measurement (1 day) ]
    Comparison of agreement of diastolic blood pressure non-invasive blood pressure recordings to invasive blood pressure levels
  • Comparison of systolic blood pressure taken with cylindrical and conical BP cuffs [ Time Frame: Single time point measurement (1 day) ]
    Comparison of systolic blood pressure taken with cylindrical and conical BP cuffs
  • Comparison of MAP taken with cylindrical and conical BP cuffs [ Time Frame: Single time point measurement (1 day) ]
    Comparison of MAP taken with cylindrical and conical BP cuffs
  • Comparison of diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs [ Time Frame: Single time point measurement (1 day) ]
    Comparison of diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pre-Eclampsia
  • Morbid Obesity
  • Parturient
  • Blood Pressure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2019)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
25
Actual Study Completion Date  ICMJE January 18, 2016
Actual Primary Completion Date January 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03222414
Other Study ID Numbers  ICMJE 150606
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Sorabella, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Sorabella, M.D. Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP