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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Pre-Eclampsia
Morbid Obesity
Parturient
Blood Pressure
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
Enrollment 3
Recruitment Details  
Pre-assignment Details 3 participants were randomized, but data was not analyzable on 2 participants. Randomization assignment was not recorded on these 2 participants.
Arm/Group Title Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical Total
Hide Arm/Group Description

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

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

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
3 participants were randomized, but data was collected incorrectly on 2 participants, so data was unusable on those 2 participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0
0
   0.0%
0
   0.0%
Between 18 and 65 years 0
1
 100.0%
1
 100.0%
>=65 years 0
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 0
1
 100.0%
1
 100.0%
Male 0
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Hide Description Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings
Time Frame Single time point measurement (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: mm Hg
-28 -6.5
2.Secondary Outcome
Title Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
Hide Description Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings
Time Frame Single time point measurement (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: mm Hg
-25 -13.5
3.Secondary Outcome
Title Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
Hide Description Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings
Time Frame Single time point measurement (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: mm Hg
-9.5 0.5
4.Secondary Outcome
Title Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
Hide Description mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs
Time Frame Single time point measurement (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Mean (Standard Deviation)
Unit of Measure: mm Hg
132.5  (2.12) 154  (1.41)
5.Secondary Outcome
Title Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
Hide Description Mean of 2 MAP readings taken with cylindrical and conical BP cuffs
Time Frame Single time point measurement (1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Mean (Standard Deviation)
Unit of Measure: mm Hg
87.5  (2.12) 101.5  (0.71)
6.Secondary Outcome
Title Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conical Cylindrical
Hide Arm/Group Description:

BP recording with noninvasive conical Ultracheck Curve BP cuff and direct invasive arterial pressure monitoring;

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

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

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

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

Overall Number of Participants Analyzed 1 1
Mean (Standard Deviation)
Unit of Measure: mm Hg
73.5  (3.54) 85  (2.83)
Time Frame 1 hour
Adverse Event Reporting Description there were 0 in that arm
 
Arm/Group Title Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical
Hide Arm/Group Description

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

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

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

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

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

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

All-Cause Mortality
Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Hide Serious Adverse Events
Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Conical Then Cylindrical Arm B: Cylindrical Then Conical
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Sorabella
Organization: Vanderbilt University Medical Center
EMail: laura.sorabella@vumc.org
Layout table for additonal information
Responsible Party: Laura Sorabella, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03222414    
Other Study ID Numbers: 150606
First Submitted: July 17, 2017
First Posted: July 19, 2017
Results First Submitted: November 20, 2019
Results First Posted: December 11, 2019
Last Update Posted: December 11, 2019