About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Child under 2 years old or > 10 years
body weight is over 40 kgs
ASA status 3 or higher
Emergency surgery or unscheduled surgery
Trial design
Single group
Treatments tested in this trial
MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
Other interventionPressure 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.