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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-10
SponsorUniversity Hospital, Lille

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children

    Other intervention

    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

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: childrenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.

Secondary outcomes

1

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

Time frame
Before the beginning of positive pressure ventilation during 1 minute
2

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

Time frame
Before the beginning of positive pressure ventilation and during 1 minute
3

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

Time frame
At the beginning of positive pressure ventilation and during two minutes

Other outcomes

Sponsors and contacts

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