Gravity Flow Technique to Validate Proper Location of Epi... | NCT03437889

Studies
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients

NCT03437889

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Nov 8, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Epidural/Anesthesia

Interventions

Cold Stimulus (Ice)

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

Nov 2022

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

Mar 20, 2018Actual

Primary Completion Date

Apr 26, 2021Actual

Completion Date

Apr 26, 2021Actual

First Submitted Date

Feb 13, 2018

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 19, 2018Actual

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

Nov 7, 2022

Last Update Posted Date

Nov 8, 2022Actual

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

Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural analgesia/anesthesia for childbirth will have epidural catheter placement per our standard procedure, which includes using the gravity flow technique to confirm that the tip (aperture) of the epidural needle is indeed located within the epidural space. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

Detailed Description

The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural analgesia/anesthesia for childbirth	Experimental		Other: Cold Stimulus (Ice)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cold Stimulus (Ice)	Other	The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of bilateral decrease of sensation to cold with ice	Loss of sensation to ice; Following epidural procedure, subjects will be assessed to see if their epidural analgesia is working by determining if they have hyperthesia to ice on lower abdomen.	30 Minutes Post Intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requesting epidural analgesia/anesthesia for childbirth
American Society of Anesthesiologists (ASA) physical status I to III
Ability to speak and read English to fully comprehend the consent process
BMI greater than 30 kg/m2

Exclusion Criteria:

Combined spinal-epidural anesthesia
Coagulopathy
History of lumbar spine surgery
Allergy or contraindication to any of the study medications
Contraindication to epidural analgesia
ASA physical status >III
BMI less than 30 kg/m2

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Patients requesting epidural analgesia/anesthesia for childbirth

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gilbert Grant, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Intervention Browse Module

MeSH Terms

ID	Term
D007053	Ice

Ancestor Terms

ID	Term
D014867	Water
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838

Browse Leaves

Not provided

Browse Branches

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