Epidural PlacementNCT03378492
Utilizing Ultrasound for Residents as an Aid in Epidural Placement
A study testing Ultrasound Guided Epidural and Standard Epidural in people with Epidural Placement, run by Yale University.
Trial summary
This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision. 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
- Epidural Placement
- What is being tested?
- Ultrasound Guided Epidural and Standard Epidural
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients presenting for vaginal delivery
- ASA-1, ASA-2, and ASA-3
- Patients with no known back deformities
- Ability to sit upright for epidural placement
- No prior lumbar surgery
- No allergies to ultrasound gel
- Pre-pregnancy BMI >= 30
Who cannot join
- Patients < 18 years of age
About this study
This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.
Read the detailed description
The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.
- Conditions
- Epidural Placement
- Being tested
- Ultrasound Guided Epidural, Standard Epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided EpiduralDevice
Sterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance.
Standard EpiduralProcedure or surgery
The point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard Epidural | Active comparator | Participants in this group will have epidurals placed using standard practice. Receives: Procedure: Standard Epidural |
| Ultrasound Guided Epidural | Experimental | Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound. Receives: Device: Ultrasound Guided Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome.
Measured: Baseline (at time of procedure)
Secondary outcomes (13)
Needle passes
A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin. This outcome will capture the number of passes.
Measured: Baseline (at time of procedure)
Needle insertion attempts
The number of needle insertion attempts is defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt.
Measured: Baseline (at time of procedure)
Accuracy of needle insertion
The accuracy of needle insertion location is determined by the need to redirect (different angle) or reinsert the needle (different skin puncture site). This outcome will describe qualitatively the accuracy of the needle placement.
Measured: Baseline (at time of procedure)
Vertebral level of epidural placement
Vertebral level of epidural placement is a record of the vertebral level where the epidural is administered. This will be confirmed via ultrasound imaging in both standard group and ultrasound group following epidural administration.
Measured: Baseline (at time of procedure)
Time to landmark identification
Time to landmark identification is defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the standard group and ultrasound group corresponds to when the resident physician first places his/her hand on the patient to palpate the back.
Measured: Baseline (at time of procedure)
Time to loss of resistance
Time to loss of resistance is defined as the time interval between the first needle puncture attempt and the observation of loss of resistance.
Measured: Baseline (at time of procedure)
Time to complete epidural analgesia administration
Time to complete epidural analgesia administration is defined as the time interval between the observation of loss of resistance and administration of analgesics through the epidural catheter.
Measured: Baseline (at time of procedure)
Total technical procedure time
Total technical procedure time is defined as the sum of (iv) Time to landmark identification, (v) Time to loss of resistance, and (vi) Time to complete epidural analgesia administration. This technical procedure time measure the time between first placing hands on the patient to the administration of analgesia.
Measured: Baseline (at time of procedure)
Epidural space depth
Epidural space depth is the depth from the skin to the epidural space as measured in centimeters (accurate to 0.1 cm).
Measured: Baseline (at time of procedure)
Pain
Pain during epidural administration: to be assessed after the completion of catheter insertion (verbal rating scale [VRS], 0-10, 0 = no pain, 10 = maximum pain).
Measured: Baseline (at time of procedure)
Analgesia efficacy rate
Analgesia efficacy rate: defined as VRS <= 1 and absence of unilateral or failed block at 20 minutes after injection of the loading dose
Measured: Baseline (at time of procedure)
Time to comfort
Time to comfort after administration of the loading dose will be recorded in minutes.
Measured: Baseline (at time of procedure)
Patient satisfaction
Patient satisfaction with the epidural administration, assessed after the administration of the loading dose (scale 0-10, 0 = not satisfied, 10 = completely satisfied).
Measured: Follow Up (Up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startAug 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: Study did not enroll, was closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural PlacementStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378492
- Sponsor's protocol ID
- 2000021722
- Status last verified
- Jan 2019
- First submitted
- 12 Dec 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Ultrasound for Residents as an Aid in Epidural Placement
- ClinicalTrials.gov ID
- NCT03378492
- Acronym / sponsor ID
- 2000021722
- Conditions
- Epidural Placement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not enroll, was closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.
Detailed description
The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Epidural | Active comparator | Procedure: Standard EpiduralParticipants in this group will have epidurals placed using standard practice. |
| Ultrasound Guided Epidural | Experimental | Device: Ultrasound Guided EpiduralParticipants in this group will have epidurals placed using standard practice with the assistance of ultrasound. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients presenting for vaginal delivery
- ASA-1, ASA-2, and ASA-3
- Patients with no known back deformities
- Ability to sit upright for epidural placement
- No prior lumbar surgery
Key exclusion criteria (1 listed)
- Patients < 18 years of age
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 |
|---|---|---|
| Ultrasound Guided EpiduralSterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. | Device | Ultrasound Guided Epidural |
| Standard EpiduralThe point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care. | Procedure or surgery | Standard Epidural |
Primary outcome
Success Rate
Time frame: Baseline (at time of procedure)
Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome.
13 secondary outcomes
Needle passes
Time frame: Baseline (at time of procedure)
Needle insertion attempts
Time frame: Baseline (at time of procedure)
Accuracy of needle insertion
Time frame: Baseline (at time of procedure)
Vertebral level of epidural placement
Time frame: Baseline (at time of procedure)
Time to landmark identification
Time frame: Baseline (at time of procedure)
Time to loss of resistance
Time frame: Baseline (at time of procedure)
Time to complete epidural analgesia administration
Time frame: Baseline (at time of procedure)
Total technical procedure time
Time frame: Baseline (at time of procedure)
Epidural space depth
Time frame: Baseline (at time of procedure)
Pain
Time frame: Baseline (at time of procedure)
Analgesia efficacy rate
Time frame: Baseline (at time of procedure)
Time to comfort
Time frame: Baseline (at time of procedure)
Patient satisfaction
Time frame: Follow Up (Up to 1 day)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Epidural and Standard Epidural in people with Epidural Placement, run by Yale University.
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 7 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: withdrawn, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Success Rate (time frame: Baseline (at time of procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2019.