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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number of needle passes [Срок оценки: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes]

Вторичные конечные точки (7)

• Number of Needle attempts [Срок оценки: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes]
• Time to obtain ultrasound images with traditional ultrasound device [Срок оценки: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes]
• Time to obtain images with automated ultrasound device [Срок оценки: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes]
• Time from local anesthetic injection till time of epidural space identification [Срок оценки: Up to 60 minutes]
• Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance [Срок оценки: Up to 60 minutes]
• Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance [Срок оценки: Up to 60 minutes]
• Patient satisfaction [Срок оценки: 15 - 20 minutes after epidural placement]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Coagulopathy
• Low platelet count
• Allergies to local anesthetics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Yale University — New Haven

Публикации

• 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. PMID 20696564
• 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. PMID 30770208
• 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. PMID 34670725
• 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. PMID 28858898

Идентификаторы

NCT: NCT05909085 · 2000034863 · No NIH funding 09.05.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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