Trial Outcomes & Findings for A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient (NCT NCT01415232)
NCT ID: NCT01415232
Last Updated: 2017-10-30
Results Overview
Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.
COMPLETED
NA
160 participants
at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)
2017-10-30
Participant Flow
From August 2010 to June 2011, a total of 160 parturients from Magee-Womens Hospital of UPMC.
Participant milestones
| Measure |
Ultrasound Measurement
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
|
|---|---|
|
Overall Study
STARTED
|
160
|
|
Overall Study
COMPLETED
|
160
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient
Baseline characteristics by cohort
| Measure |
Ultrasound Measurement
n=160 Participants
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
160 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)Population: per protocol
Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.
Outcome measures
| Measure |
Ultrasound Measurement
n=160 Participants
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
|
|---|---|
|
Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)
Ultrasound Longitudinal Plane
|
0.905 correlation coefficient
Interval 0.873 to 0.929
|
|
Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)
Ultrasound Transverse Plane
|
0.899 correlation coefficient
Interval 0.865 to 0.925
|
Adverse Events
Ultrasound Measurement
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