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

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ClinicalTrials.gov Identifier: NCT03222414
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
James Lozada, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Morbid Obesity Parturient Blood Pressure 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: conical Ultra Curve BP cuff
Non-invasive BP recording with conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring
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

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

Active Comparator: traditional cylindrical BP cuff
Non-invasive BP recording with traditional cylindrical BP cuff and direct invasive arterial pressure monitoring
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222414


Contacts
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Contact: Laura Sorabella, M.D. 615-322-8476 laura.l.sorabella@vumc.org
Contact: Gail Mayo, RN 615-936-1705 gail.mayo@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Laura Sorabella, M.D.    615-322-8476    laura.l.sorabella@vumc.org   
Contact: Gail Mayo, RN    615-936-1705    gail.mayo@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Laura Sorabella, M.D. Vanderbilt University Medical Center

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Responsible Party: James Lozada, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03222414     History of Changes
Other Study ID Numbers: 150606
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms