A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

NCT01415232 | Completed Results DMC

• 1 other identifier: PRO10070214
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the correlation between actual epidural needle depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best of our knowledge the use of an epidural depth equation, which was developed in an earlier study using height and weight, with ultrasound visualization will improve identification of the epidural space.

Conditions

Obesity

Keywords

Obesity; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)

  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.

  at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)

Study Arms (1)

Ultrasound measurement

EXPERIMENTAL

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)

Interventions

Sonosite S-Nerve® US system (SonoSite, Bothell,WA) DEVICE

Ultrasound to measure depth to the epidural space in morbidly obese parturients

Also known as: Ultrasound machine, Sonosite

Ultrasound measurement

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All women of childbearing age (including children aged 14 years and above) with a BMI \> 40kg/m2 who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study. Men will not be included since they can not become pregnant. All patients will be recruited at Magee-Womens Hospital.

You may not qualify if:

• Patients with severe preeclampsia will be excluded from the study, as these patients may have significant edema which could alter ultrasound and/or epidural needle depth measurement. Patients with a history of back surgery, significant scoliosis, and/or lumbar pathology (i.e. Ankylosing Spondylitis) will be excluded from the study because these conditions could complicate ultrasound visualization and/or epidural needle placement.

Sponsors & Collaborators

• Manuel C. Vallejo: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Manuel Vallejo
• Organization: UPittsburgh'

vallejomc@anes.upmc.edu

4126414260

Study Officials

• Manuel C. Vallejo, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 30, 2017
• Results First Posted: May 3, 2013

Record last verified: 2017-09

Locations

US (1)