Epidural Catheter Thread Between Two Different Vendors

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Device: Arrow Catheter Kit.; Device: B.Braun Catheter Kit

• Registration Number: NCT03722446
• Lead Sponsor: University of Michigan

Brief Summary

The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different epidural pain management kits vendors

Detailed Description

The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different pain management kits. In order to improve patient care, if there is a difference in the time to thread epidurals with one kit over the other, we would like to use the kit with decreased time to thread in the future.

Study Timeline

• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2018-11-16
• Primary Completion: 2019-09-21
• Study Completion: 2019-09-21
• Status Verified: 2020-09
• Results First Submitted: 2020-09-12
• Results First Submitted QC: 2020-09-12
• Last Update Submitted: 2020-09-12
• Results First Posted: 2020-10-06
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

Inclusion Criteria

women in labor

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arrow Catheter Kit.	Arrow Catheter Kit.	Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.
B.Braun Catheter Kit	B.Braun Catheter Kit	Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a Successful Thread at First Pass	within 60min of first attempt at placement	A thread is considered successful at first pass if there were no minor or major manipulations required.

Secondary Outcome Measures

Name	Time	Method
Incidence of Epidural Intravascular Cannulations	within 60min of first attempt at placement	Count of participants for whom there was an incidence of epidural intravascular cannulation
Incidence of Paresthesia	within 60min of first attempt at placement	Count of participants for whom there was an incidence of paresthesia
Time to Thread Epidural Catheter	within 60min of first attempt at placement	At the epidural placement, total amount of time required to establish successful epidural catheter thread
Incidence of Unintended Dural Punctures	within 60min of first attempt at placement	Count of participants for whom there was an unintended dural puncture after placement
Epidural Needle Manipulations Needed to Successfully Advance	within 60min of first attempt at placement	For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter

Trial Locations

Locations (1)

von Voitlander Women's Hospital; 🇺🇸 Ann Arbor, Michigan, United States