Epidural Catheter Thread Between Two Different Vendors

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03722446

Enrollment

257

Registered

2018-10-29

Start date

2018-11-16

Completion date

2019-09-21

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

DEVICEArrow Catheter Kit.

The group will be randomized to receive this labor analgesia kit.

DEVICEB.Braun Catheter Kit

The group will be randomized to receive this labor analgesia kit.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

women in labor \-

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Participant flow

Recruitment details

Patients in labor requesting epidural analgesia for an expected vaginal delivery.

Pre-assignment details

Participants were excluded if there was a fetal loss involved.

Participants by arm

Arm	Count
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. Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit.	120
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. B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit.	120
Total	240

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	15	2

Baseline characteristics

Characteristic	B.Braun Catheter Kit	Total	Arrow Catheter Kit.
Age, Continuous	30 years STANDARD_DEVIATION 6	30 years STANDARD_DEVIATION 6	30 years STANDARD_DEVIATION 5
BMI	31.6 kg/m^2 STANDARD_DEVIATION 6.7	31.6 kg/m^2 STANDARD_DEVIATION 6.2	31.5 kg/m^2 STANDARD_DEVIATION 5.6
Cervical Dilation	4 cm STANDARD_DEVIATION 2	4 cm STANDARD_DEVIATION 2	4 cm STANDARD_DEVIATION 2
Gestational Age	38.6 weeks STANDARD_DEVIATION 2.6	38.8 weeks STANDARD_DEVIATION 2.1	38.9 weeks STANDARD_DEVIATION 1.5
Race and Ethnicity Not Collected	—	0 Participants	—
Sex: Female, Male Female	120 Participants	240 Participants	120 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 120	0 / 120
other Total, other adverse events	0 / 120	0 / 120
serious Total, serious adverse events	0 / 120	0 / 120

Outcome results

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.