Ultrasound High BMI Study | NCT05052658

Studies
Ultrasound High BMI Study

NCT05052658

Sponsor

University of Kentucky

Status

Completed

Last Update Posted

Jan 25, 2023Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Obesity Complicating Childbirth

Interventions

Neuraxial block placement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2021Actual

Primary Completion Date

Dec 13, 2022Actual

Completion Date

Dec 13, 2022Actual

First Submitted Date

Sep 13, 2021

First Submission Date that Met QC Criteria

Sep 13, 2021

First Posted Date

Sep 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2023

Last Update Posted Date

Jan 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.

Detailed Description

Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This somewhat "blind" technique to identify the spinal space becomes more difficult and less reliable in obese patients. Ultrasound devices have become common and successful with blocks and venous access, both involving mostly soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and a long learning curve. A newly developed pocket-size ultrasound addresses these limitations by providing real-time pattern recognition for spinal bony structures and 3D overlay for recognition of midline spinous process and intervertebral space using an automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will reduce time to epidural placement and reduce number of passes in obese patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palpation Group	Active Comparator		Procedure: Neuraxial block placement
Ultrasound Group	Experimental		Procedure: Neuraxial block placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuraxial block placement	Procedure	The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.	Palpation Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to placement of neuraxial block in parturients with BMI=35-59.9	Time period from initially touching the patient's skin to removal of Tuohy needle after catheter placement.	Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Number of passes to placement of neuraxial block in parturients with BMI=35-59.9	Number of times the epidural needle is removed from skin and re-entered	Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
Subject with American Society of Anesthesiologists score equal to or less than III.
Subject with singleton gestation equal to or greater than 37 weeks.
Subjects with planned labor epidural in sitting position.

Exclusion Criteria:

Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
Patients with major back abnormalities (back surgery, significant scoliosis).
Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
Patients having cesarean section or combined spinal epidural.
Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
Patient needing a translator for procedure.
Patients who are prisoners.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Regina Fragneto, MD	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky Medical Center		Lexington	Kentucky	40536	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided