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Набор по приглашению NCT06982027

Peripheral Regional Blockade and EMG

Без фазы С лечением Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BlockSynop surface electromyography device, Peripheral nerve block.
Кому может быть актуально
Состояния в реестре: Surgery. Базовые параметры: 0 лет — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity

Обзор

The investigators are studying a type of technology that is already used called surface electromyography (EMG). This measures and records electrical activity using sensor stickers in a non-invasive way. The purpose of this study is to use a prototype/test surface EMG machine to measure how well regional anesthesia (nerve block) is working. This device is non-invasive and being used for research use as an unapproved medical device. The information may teach us how to give nerve blocks more safely and effectively. Study participation: Subjects having surgery will have the surface EMG sensor stickers placed on their arms or legs before surgery. These will stay on during surgery and for part of recovery. Study visits: The study will consist of 1 visit that starts in the pre-operative area, through the surgery, and for part of recovery time after surgery.

Подробное описание

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize peripheral nerve blockade (upper or lower extremity) in pediatric, adolescent, and young adult patients undergoing surgery. We also aim to quantify the impact of sevoflurane (general anesthesia) on basal muscle tone based on EMG changes.

Hypothesis: EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

Вмешательства

  • Устройство BlockSynop surface electromyography device
    The EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device.
  • Процедура Peripheral nerve block
    An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.

Первичные конечные точки

  • Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude. [Срок оценки: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day.]
  • Determine resolution of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude. [Срок оценки: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.]
  • Determine density of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude. [Срок оценки: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.]
Вторичные конечные точки (1)
  • Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. [Срок оценки: Intraoperative time frame. Timeframe being day of surgery.]

Критерии участия

Критерии включения

  • Patients ≤ 21 years of age
  • Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used

Критерии исключения

  • Patients > 21 years of age
  • Parent / patient refusal
  • Premature infants; neuromuscular disease; systemic infection; hemodynamic instability; coagulation disorder; degenerative CNS abnormality that precludes regional anesthesia; and local anesthetic allergy; pregnant women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Nationwide Children's Hospital — Columbus

Идентификаторы

NCT: NCT06982027 · STUDY00004642

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗