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

RecruitingNAAges 2 Years - 10 YearsAllUniversity Hospital, Lille
NCT05279170 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Child under 2 years old or \> 10 years * body weight is over 40 kgs * ASA status 3 or higher * Emergency surgery or unscheduled surgery * scheduled ENT or esogastric surgery * Achalasia of the esophagus or history of GERD pathology * History of esophageal surgery (NISSEN type) * BMI indexed to age and sex showing childhood obesity * Predictable mask ventilation difficulties * History of Tracheostomy * Child not insured by social security
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What it tests

  • MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
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Where

2 sites
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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