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

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

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

Study Overview

• Status: Recruiting
• Conditions: Surgery; Anesthesia Intubation Complication
• Intervention / Treatment: Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
    • Contact: Dina BERT, Dr; Phone Number: 03 20 44 62 69; Email: dina.bert@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: children; Compression of adjacent vessels (jugular vein and carotid artery), near the left paratracheal area. The risk of compression of the vessels will be assessed before performing the maneuver. At the screening time before the intervention, we will perfom an ultrasonography measurement while we applied the maneuver in order to eliminate a risk of compression of the vessels, defined as a reduction in diameter of 50%.

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography	Presence of antral and/or gastric air artefact described in ultrasonography. US will be perform during positive pressure mask ventilation.	We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Left side of the trachea ultrasonography performed before positive pressure ventilation	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.	Left side of the trachea ultrasonography performed before positive pressure ventilation	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.	Expired tidal volume measured exhaled flow on anesthesia ventilator	At the beginning of positive pressure ventilation and during two minutes

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: children; elective surgery; Echography; Low Left Paratracheal esophagus Pressure; gastric insufflation; positive pressure ventilation
• Other Study ID Numbers: 2020_74; 2021-A01535-36 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No