Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05279170
Acronym
MAVEPPIC
Enrollment
72
Registered
2022-03-15
Start date
2024-06-06
Completion date
2027-06-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complication, Surgery

Keywords

Low Left Paratracheal esophagus Pressure, gastric insufflation, Echography, children, elective surgery, positive pressure ventilation

Brief summary

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

Interventions

OTHERMAVEPPIC: 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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonographyWe will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.Presence of antral and/or gastric air artefact described in ultrasonography. US will be perform during positive pressure mask ventilation.

Secondary

MeasureTime frameDescription
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)Before the beginning of positive pressure ventilation during 1 minuteLeft side of the trachea ultrasonography performed before positive pressure ventilation
The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US.Before the beginning of positive pressure ventilation and during 1 minuteLeft side of the trachea ultrasonography performed before positive pressure ventilation
The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP.At the beginning of positive pressure ventilation and during two minutesExpired tidal volume measured exhaled flow on anesthesia ventilator

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026