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

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05279170

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Surgery Anesthesia Intubation Complication	Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography [We 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 Outcome Measures

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 minute]
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. [Before the beginning of positive pressure ventilation and during 1 minute]
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. [At the beginning of positive pressure ventilation and during two minutes]
Expired tidal volume measured exhaled flow on anesthesia ventilator

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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