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A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonosite S-Nerve® US system (SonoSite, Bothell,WA)
Sponsored by
Manuel C. Vallejo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring Obesity, Ultrasound

Eligibility Criteria

14 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Magee-Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound measurement

Arm Description

Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2011
Last Updated
September 27, 2017
Sponsor
Manuel C. Vallejo
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1. Study Identification

Unique Protocol Identification Number
NCT01415232
Brief Title
A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel C. Vallejo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound measurement
Arm Type
Experimental
Arm Description
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
Intervention Type
Device
Intervention Name(s)
Sonosite S-Nerve® US system (SonoSite, Bothell,WA)
Other Intervention Name(s)
Ultrasound machine, Sonosite
Intervention Description
Ultrasound to measure depth to the epidural space in morbidly obese parturients
Primary Outcome Measure Information:
Title
Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)
Description
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.
Time Frame
at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel C. Vallejo, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

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