The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device

Labor Analgesia Clinical Trial

Official title:

A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05909085
• Other study ID #: 2000034863
• Secondary ID: No NIH funding 0
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Antonio Gonzalez, MD
• Phone: 4133869415
• Email: Antonio.Gonzalez-fiol[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Device:
• Traditional ultrasound
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
• Automated ultrasound
Labor epidural will be performed after marking patient skin using an automated ultrasound device

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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 wom — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of needle passes	Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.	From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Secondary	Number of Needle attempts	Number of times the needle is advanced in and out of the skin	From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Secondary	Time to obtain ultrasound images with traditional ultrasound device	Time from placing ultrasound on patients back until markings are complete	Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Secondary	Time to obtain images with automated ultrasound device	Time from placing ultrasound on patients back until markings are complete	Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Secondary	Time from local anesthetic injection till time of epidural space identification	Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance	Up to 60 minutes
Secondary	Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance	Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.	Up to 60 minutes
Secondary	Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance	Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.	Up to 60 minutes
Secondary	Patient satisfaction	Assessed after the administration of the loading dose. Patient will be asked to rate their pain on a scale 0-10, 0 = not satisfied, 10 = completely satisfied	15 - 20 minutes after epidural placement