Идёт набор NCT05279170

MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children

Без фазы С лечением Surgery Anesthesia Intubation Complication

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: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children.
Кому может быть актуально: Состояния в реестре: Surgery, Anesthesia Intubation Complication. Базовые параметры: 2 лет — 10 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: Франция
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

Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study

Обзор

The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects. A new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children

Вмешательства

Другое MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
Pressure will be applied with two fingers in the area located between the trachea and the sternal head of the sternocleidomastoid muscle on the left side to compress the cervical esophagus. The force applied (after measuring the equivalent force applied on a precision scale) will be about 10 - 15 N. This force will be adapted according to the child's body weight : 10 N below 20 kgs and 15 N between 20 kgs and 40 kgs

Первичные конечные точки

Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography [Срок оценки: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.]

Вторичные конечные точки (3)

The verification of the actual position of the esophagus on the left side of the trachea at the place where LPPP will be applied (feasibility of LLPP) [Срок оценки: Before the beginning of positive pressure ventilation during 1 minute]
The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US. [Срок оценки: Before the beginning of positive pressure ventilation and during 1 minute]
The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP. [Срок оценки: At the beginning of positive pressure ventilation and during two minutes]

Критерии участия

Критерии включения

Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation
inhalation induction
elective surgery
ASA status 1 or 2
consent of the child if he/she is able to express it
consent of both parents and/or legal guardians
socially insured