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

University Hospital, Lille

Status: Enrolling

Conditions: Surgery; Anesthesia Intubation Complication

Treatments: Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children

Study type: Interventional

Funder types: Other

Identifiers

NCT05279170

2020_74

2021-A01535-36 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No 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

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

children

Experimental group

Description:

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%.

Treatment:

Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children