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

Not Applicable

• Conditions: Anesthesia Intubation Complication; Surgery

• Registration Number: NCT05279170
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-24
• Study Start: 2022-03
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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