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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date December 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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
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

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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