Actively Recruiting

Phase Not Applicable
Age: 2Years - 10Years
All Genders
NCT05279170

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

Led by University Hospital, Lille · Updated on 2025-12-26

72

Participants Needed

2

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Child under 2 years old or over 10 years
  • Body weight is over 40 kilograms
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique

Lille, France

Actively Recruiting

2

Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique

Lille, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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