EpiFaith Resident Learning Curve Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EpiFaith epidural syringe, Control (glass) syringe.
- Who it may be relevant to
- Registry conditions: Epidural Analgesia, Epidural Analgesia for Labour and Delivery, Learning Curve. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of the EpiFaith® Syringe on the Learning Curve of Anesthesia Residents for the Labor Epidural Technique: A Quasi-Experimental Study
Overview
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.
Detailed description
The lumbar epidural technique for labor analgesia requires technical training and a manual skillset. A prior study evaluating anesthesia resident learning curves for a traditional labor epidural technique demonstrated a steep learning curve for the first 20 epidural placements, followed by a plateau with gradual proficiency maximized after 60 epidural placements (1). A prior study evaluated a spring-loaded epidural syringe among experienced providers (2). However, the impact of a spring-loaded epidural syringe on novice anesthesia resident learning curves is unknown. In addition, the impact of EpiFaith® use at the time of manual skill acquisition on success with subsequent traditional epidural technical skills is unknown.
The EpiFaith® syringe is FDA-cleared and has a spring-loaded piston designed to detect entry into the epidural space upon loss of resistance (LOR) as the epidural needle tip moves from the dense ligamentum flavum to the high-compliance epidural space. Performing the LOR technique using the EpiFaith® syringe, the piston within the syringe moves forward driven by spring force when a drop in pressure is detected. Piston movement within the syringe is visibly detectable with a yellow indicator in the syringe when LOR occurs. In a feasibility study of 40 labor epidural placements, 3 of 4 expert obstetric anesthesiology physicians reported the EpiFaith® syringe to be equal to superior in quality to the standard LOR syringe, with 100% success rate and no inadvertent dural punctures (3).
Evaluating the impact of the EpiFaith® syringe on learning curves of anesthesia residents with minimal prior technical experience will help inform how we approach education regarding the labor epidural technique. Steeper learning curves with faster time to proficiency may benefit both patients and supervising staff, while if no difference is determined, the use of the EpiFaith® syringe can be de-emphasized during the training period.
Interventions
- Device EpiFaith epidural syringe
The EpiFaith syringe is an FDA-cleared epidural syringe. - Device Control (glass) syringe
glass epidural syringe
Primary outcome measures
- success of labor epidural attempt [Time frame: time of epidural placement to 30 minutes after dosing of the epidural]
Secondary outcome measures (4)
- rating of the epidural syringe [Time frame: from time of placement to immediately following placement]
- Incidence of inadvertent dural puncture [Time frame: from time of epidural placement for a maximum of 5 days]
- incidence of postdural puncture headache [Time frame: from time of epidural placement up to 5 days]
- Need for epidural catheter replacement during labor [Time frame: from time of epidural placement through delivery during hospital admission]
Eligibility criteria
Inclusion criteria
- Anesthesiology residents with fewer than 5 prior epidural placement experiences
Exclusion criteria
- anesthesiology residents with more than 5 prior epidural placement experiences
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT07395622 · 2023P001926 · 2023A006350