Epidural Catheter Thread Between Two Different Vendors

A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.

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

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: Arrow Catheter Kit.; Device: B.Braun Catheter Kit

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 Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • von Voitlander Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria: women in labor

-

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Arrow Catheter Kit.; The group will be randomized to receive this labor analgesia kit.
Other: 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.	Device: B.Braun Catheter Kit; The group will be randomized to receive this labor analgesia kit.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Carlo Pancaro, MD, University of Michigan

Publications and helpful links

General Publications

• Pancaro C, Purtell J, LaBuda D, Saager L, Klumpner TT, Dubovoy T, Rajala B, Singh S, Cassidy R, Vahabzadeh C, Maxwell S, Manica V, Eckmann DM, Mhyre JM, Engoren MC. Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial. Anesth Analg. 2021 Jul 1;133(1):151-159. doi: 10.1213/ANE.0000000000005526.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): September 21, 2019
• Study Completion (Actual): September 21, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 00143333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No