Epidural Catheter Thread Between Two Different Vendors

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722446
• Other study ID #: 00143333
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: September 21, 2019

Study information

• Verified date: September 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 21, 2019
• Est. primary completion date: September 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria: women in labor

-

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Arrow Catheter Kit.
The group will be randomized to receive this labor analgesia kit.
• B.Braun Catheter Kit
The group will be randomized to receive this labor analgesia kit.

Locations

Country	Name	City	State
United States	von Voitlander Women's Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of Paresthesia	Count of participants for whom there was an incidence of paresthesia	within 60min of first attempt at placement
Secondary	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
Secondary	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