Trial Outcomes & Findings for Epidural Catheter Thread Between Two Different Vendors (NCT NCT03722446)
NCT ID: NCT03722446
Last Updated: 2020-10-06
Results Overview
A thread is considered successful at first pass if there were no minor or major manipulations required.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
within 60min of first attempt at placement
Results posted on
2020-10-06
Participant Flow
Patients in labor requesting epidural analgesia for an expected vaginal delivery.
Participants were excluded if there was a fetal loss involved.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
122
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
15
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
15
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 5 • n=120 Participants
|
30 years
STANDARD_DEVIATION 6 • n=120 Participants
|
30 years
STANDARD_DEVIATION 6 • n=240 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=120 Participants
|
120 Participants
n=120 Participants
|
240 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=120 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=240 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Gestational Age
|
38.9 weeks
STANDARD_DEVIATION 1.5 • n=120 Participants
|
38.6 weeks
STANDARD_DEVIATION 2.6 • n=120 Participants
|
38.8 weeks
STANDARD_DEVIATION 2.1 • n=240 Participants
|
|
BMI
|
31.5 kg/m^2
STANDARD_DEVIATION 5.6 • n=120 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 6.7 • n=120 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 6.2 • n=240 Participants
|
|
Cervical Dilation
|
4 cm
STANDARD_DEVIATION 2 • n=120 Participants
|
4 cm
STANDARD_DEVIATION 2 • n=120 Participants
|
4 cm
STANDARD_DEVIATION 2 • n=240 Participants
|
PRIMARY outcome
Timeframe: within 60min of first attempt at placementA thread is considered successful at first pass if there were no minor or major manipulations required.
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Number of Participants Who Experienced a Successful Thread at First Pass
|
81 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: within 60min of first attempt at placementAt the epidural placement, total amount of time required to establish successful epidural catheter thread
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Time to Thread Epidural Catheter
|
135 seconds
Standard Deviation 186
|
51 seconds
Standard Deviation 31
|
SECONDARY outcome
Timeframe: within 60min of first attempt at placementCount of participants for whom there was an unintended dural puncture after placement
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Incidence of Unintended Dural Punctures
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 60min of first attempt at placementCount of participants for whom there was an incidence of paresthesia
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Incidence of Paresthesia
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: within 60min of first attempt at placementCount of participants for whom there was an incidence of epidural intravascular cannulation
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Incidence of Epidural Intravascular Cannulations
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 60min of first attempt at placementFor each participant, the number of total manipulations (major or minor) needed to successfully advance catheter
Outcome measures
| Measure |
Arrow Catheter Kit.
n=120 Participants
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.
|
B.Braun Catheter Kit
n=120 Participants
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.
|
|---|---|---|
|
Epidural Needle Manipulations Needed to Successfully Advance
0 manipulations
|
81 Participants
|
117 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
1 manipulation
|
19 Participants
|
2 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
2 manipulations
|
6 Participants
|
0 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
3 manipulations
|
6 Participants
|
0 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
4 manipulations
|
5 Participants
|
0 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
5 manipulations
|
2 Participants
|
1 Participants
|
|
Epidural Needle Manipulations Needed to Successfully Advance
6 manipulations
|
1 Participants
|
0 Participants
|
Adverse Events
Arrow Catheter Kit.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B.Braun Catheter Kit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carlo Pancaro
University of Michigan - Department of Anesthesiology
Phone: 617-435-5403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place