Superiority of Epidural Placement Technique Using EpiFait... | NCT04793373

Studies
Superiority of Epidural Placement Technique Using EpiFaith Syringe

NCT04793373

Sponsor

Harvard Medical School (HMS and HSDM)

Status

Withdrawn

Last Update Posted

Jul 21, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Syringe

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol is being revised.

Expanded Access Info

Start Date

May 15, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Mar 9, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 11, 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

Jul 19, 2023

Last Update Posted Date

Jul 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jie Zhou, Assistant Professor, Harvard Medical School (HMS and HSDM)Principal Investigator

Lead Sponsor

Harvard Medical School (HMS and HSDM)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Detailed Description

We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EpiFaith® group	Experimental	Study subject will have the epidural placement with an EpiFaith® syringe.	Device: Syringe
Conventional group	Active Comparator	Study subject will have the epidural placement with a conventional glass syringe.	Device: Syringe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Syringe	Device	A syringe will be used to detect the loss of resistance and needle's entry of epidural space.	Conventional group EpiFaith® group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of epidural localization	Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females 18 years of age and older at screening
Request labor epidural analgesia
Able to give informed consent to participate in the study
American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
BMI ≤ 40 kg/m2

Exclusion Criteria:

BMI > 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
Any allergy to bupivacaine or fentanyl

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Parturients who require labor epidural placement

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States