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

NCT03222414 | Terminated Results FDA Device

• 1 other identifier: 150606
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia; Morbid Obesity; Parturient; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

  Single time point measurement (1 day)

Secondary Outcomes (5)

• Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring

  Single time point measurement (1 day)

• Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement

  Single time point measurement (1 day)

• Mean of 2 Systolic Blood Pressure 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

  Single time point measurement (1 day)

• Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs

  Single time point measurement (1 day)

Study Arms (2)

Arm A: Conical then Cylindrical

EXPERIMENTAL

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

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

Arm B: Cylindrical then Conical

ACTIVE COMPARATOR

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

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

Interventions

Non-invasive BP recording with conical Ultracheck Curve BP cuff DEVICE

Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff

Arm A: Conical then Cylindrical; Arm B: Cylindrical then Conical

Non-invasive BP recording with traditional cylindrical BP cuff DEVICE

Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff

Arm A: Conical then Cylindrical; Arm B: Cylindrical then Conical

Direct invasive arterial pressure OTHER

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

Arm A: Conical then Cylindrical; Arm B: Cylindrical then Conical

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parturients admitted in labor

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 32748394 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Obesity, Morbid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Sorabella
• Organization: Vanderbilt University Medical Center

laura.sorabella@vumc.org

Study Officials

• Laura Sorabella, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: May 1, 2015
• Primary Completion: January 18, 2016
• Study Completion: January 18, 2016
• Last Updated: December 11, 2019
• Results First Posted: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)