Labor PainNCT03722446
Epidural Catheter Thread Between Two Different Vendors
A study testing Arrow Catheter Kit. and B.Braun Catheter Kit in people with Labor Pain, run by University of Michigan at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Arrow Catheter Kit. and B.Braun Catheter Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 21 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
von Voitlander Women's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 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
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Arrow Catheter Kit., B.Braun Catheter Kit
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrow Catheter Kit.Device
The group will be randomized to receive this labor analgesia kit.
B.Braun Catheter KitDevice
The group will be randomized to receive this labor analgesia kit.
| Study group | Role | What they receive |
|---|---|---|
| Arrow Catheter Kit. | Other | 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. Receives: Device: Arrow Catheter Kit. |
| B.Braun Catheter Kit | Other | 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. Receives: Device: B.Braun Catheter Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 60min of first attempt at placement
Secondary outcomes (5)
Time to Thread Epidural Catheter
At the epidural placement, total amount of time required to establish successful epidural catheter thread
Measured: 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
Measured: within 60min of first attempt at placement
Incidence of Paresthesia
Count of participants for whom there was an incidence of paresthesia
Measured: 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
Measured: 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
Measured: within 60min of first attempt at placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start16 Nov 2018
- Primary completion21 Sep 2019
- Study completion21 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Pancaro, University of Michigan
- Investigators
- Carlo Pancaro, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722446
- Sponsor's protocol ID
- 00143333
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2018
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
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.
PubMed 33835077
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.
- ClinicalTrials.gov ID
- NCT03722446
- Acronym / sponsor ID
- 00143333
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 21 Sep 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 6 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arrow Catheter Kit. | Other | Device: 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 | Other | Device: B.Braun Catheter KitPerifix 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrow Catheter Kit.The group will be randomized to receive this labor analgesia kit. | Device | Arrow Catheter Kit. |
| B.Braun Catheter KitThe group will be randomized to receive this labor analgesia kit. | Device | B.Braun Catheter Kit |
Primary outcome
Number of Participants Who Experienced a Successful Thread at First Pass
Time frame: within 60min of first attempt at placement
A thread is considered successful at first pass if there were no minor or major manipulations required.
5 secondary outcomes
Time to Thread Epidural Catheter
Time frame: within 60min of first attempt at placement
Incidence of Unintended Dural Punctures
Time frame: within 60min of first attempt at placement
Incidence of Paresthesia
Time frame: within 60min of first attempt at placement
Incidence of Epidural Intravascular Cannulations
Time frame: within 60min of first attempt at placement
Epidural Needle Manipulations Needed to Successfully Advance
Time frame: within 60min of first attempt at placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33835077Pancaro 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.
- Individual participant dataSharing planned: Yes
Related trials for Labor Pain
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruiting
Elevated Midline Positioning During Diaper Change in Preterm Infants
Infant, Premature, Diseases, Premature Birth of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Pancaro, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrow Catheter Kit. and B.Braun Catheter Kit in people with Labor Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Successful Thread at First Pass (time frame: within 60min of first attempt at placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.