Trial Outcomes & Findings for Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia (NCT NCT03222414)
NCT ID: NCT03222414
Last Updated: 2019-12-11
Results Overview
Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Single time point measurement (1 day)
Results posted on
2019-12-11
Participant Flow
3 participants were randomized, but data was not analyzable on 2 participants. Randomization assignment was not recorded on these 2 participants.
Participant milestones
| Measure |
Arm A: Conical Then Cylindrical
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
|
Arm B: Cylindrical Then Conical
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
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A: Conical Then Cylindrical
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
|
Arm B: Cylindrical Then Conical
n=1 Participants
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
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Single time point measurement (1 day)Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement
|
-28 mm Hg
|
-6.5 mm Hg
|
SECONDARY outcome
Timeframe: Single time point measurement (1 day)Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring
|
-25 mm Hg
|
-13.5 mm Hg
|
SECONDARY outcome
Timeframe: Single time point measurement (1 day)Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement
|
-9.5 mm Hg
|
0.5 mm Hg
|
SECONDARY outcome
Timeframe: Single time point measurement (1 day)mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs
|
132.5 mm Hg
Standard Deviation 2.12
|
154 mm Hg
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Single time point measurement (1 day)Mean of 2 MAP readings taken with cylindrical and conical BP cuffs
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs
|
87.5 mm Hg
Standard Deviation 2.12
|
101.5 mm Hg
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Single time point measurement (1 day)Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs
Outcome measures
| Measure |
Conical
n=1 Participants
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
|
Cylindrical
n=1 Participants
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
|
|---|---|---|
|
Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs
|
73.5 mm Hg
Standard Deviation 3.54
|
85 mm Hg
Standard Deviation 2.83
|
Adverse Events
Arm A: Conical Then Cylindrical
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Cylindrical Then Conical
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place