A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient
|ClinicalTrials.gov Identifier: NCT01415232|
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : May 3, 2013
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment|
|Obesity||Device: Sonosite S-Nerve® US system (SonoSite, Bothell,WA)|
The investigators plan to enroll women who are morbidly obese (BMI > 40 kg/m2) and request epidural analgesia for labor. After written informed consent, 160 patients will have the use of the epidural depth equation with ultrasound (EQ-US) to estimate epidural depth (Est-D). US visualization of the epidural space will be completed by the principle investigator who has had extensive training in epidural US visualization. The EQ-US depth will be recorded. After US use, another provider who is listed as an investigator will place the epidural catheter without prior knowledge of the estimated epidural depth with the use of the equation and US. The actual needle depth to the epidural space (ND) will be recorded.
Data collected from the patient's medical record will include demographic data (age, height, weight) gravidity, parity, and cervical dilation. Measured variables will include the estimated epidural depth (Est-D) as measured by the epidural depth equation with the use of ultrasound (EQ-US), and actual epidural needle depth (ND). The investigators believe that the use of ultrasound with the epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients will have a high correlation with actual epidural needle depth (ND).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Ultrasound With the Epidural Depth Equation (EQ-US) to Estimate Epidural Depth (Est-D) in Morbidly Obese Parturients (BMI>40Kg/m2) Will Have a High Correlation With Actual Epidural Needle Depth (ND)|
|Study Start Date :||August 2010|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Experimental: Ultrasound measurement
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
Device: Sonosite S-Nerve® US system (SonoSite, Bothell,WA)
Ultrasound to measure depth to the epidural space in morbidly obese parturients
- Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D) [ Time Frame: at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415232
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Manuel C. Vallejo, M.D.||Magee-Womens Hospital of UPMC|