NCT05279170

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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

Conditions

• Surgery
• Anesthesia Intubation Complication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-06
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-03-15
• Last updated: 2025-12-26

Locations

2 sites across 1 country: France