Clinical trial NCT05909085: The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device
Official title: A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Analgesia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

Detailed description: Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study).

Number of needle insertion attempts: 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. Time to landmark identification: 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 LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Coagulopathy
* Low platelet count
* Allergies to local anesthetics

Primary outcomes:
measure: Number of needle passes
timeFrame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Secondary outcomes:
measure: Number of Needle attempts
timeFrame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
measure: Time to obtain ultrasound images with traditional ultrasound device
timeFrame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
measure: Time to obtain images with automated ultrasound device
timeFrame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
measure: Time from local anesthetic injection till time of epidural space identification
timeFrame: Up to 60 minutes
measure: Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance
timeFrame: Up to 60 minutes
measure: Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance
timeFrame: Up to 60 minutes
measure: Patient satisfaction
timeFrame: 15 - 20 minutes after epidural placement
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Antonio Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
citation: Carvalho B, Seligman KM, Weiniger CF. The comparative accuracy of a handheld and console ultrasound device for neuraxial depth and landmark assessment. Int J Obstet Anesth. 2019 Aug;39:68-73. doi: 10.1016/j.ijoa.2019.01.004. Epub 2019 Jan 11.
citation: Weiniger CF, Carvalho B, Ronel I, Greenberger C, Aptekman B, Almog O, Kagan G, Shalev S. A randomized trial to investigate needle redirections/re-insertions using a handheld ultrasound device versus traditional palpation for spinal anesthesia in obese women undergoing cesarean delivery. Int J Obstet Anesth. 2022 Feb;49:103229. doi: 10.1016/j.ijoa.2021.103229. Epub 2021 Sep 23.
citation: Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.