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

Official title

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

Overview

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

Interventions

• 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

Primary outcome measures

• Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography [Time frame: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.]

Secondary outcome measures (3)

• 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) [Time frame: Before the beginning of positive pressure ventilation during 1 minute]
• The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US. [Time frame: Before the beginning of positive pressure ventilation and during 1 minute]
• The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP. [Time frame: At the beginning of positive pressure ventilation and during two minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

France · 2 centers

• Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique — Lille
• Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique — Lille

Identifiers

NCT: NCT05279170 · 2020_74 · 2021-A01535-36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗