Blood Pressure Clinical Trial
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
NCT number | NCT03222414 |
Other study ID # | 150606 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2015 |
Est. completion date | January 18, 2016 |
Verified date | December 2019 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | January 18, 2016 |
Est. primary completion date | January 18, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Single time point measurement (1 day) | |
Secondary | 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 | Single time point measurement (1 day) | |
Secondary | 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 | Single time point measurement (1 day) | |
Secondary | Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs | Mean of 2 MAP readings taken with cylindrical and conical BP cuffs | Single time point measurement (1 day) | |
Secondary | 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 | Single time point measurement (1 day) |
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