RecruitingNot ApplicableNCT05279170

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

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

Sponsor

University Hospital, Lille

Enrollment

72 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Anesthesia Intubation Complication

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

Eligibility

Min Age: 2 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether applying gentle pressure on the throat (paratracheal compression) during mask ventilation in children under general anesthesia prevents air from entering the stomach (gastric insufflation), which can increase the risk of vomiting and aspiration. You may be eligible if: - Your child is between 2 and 10 years old - Your child is having elective (non-emergency) surgery under general anesthesia that includes inhalation induction - Your child weighs 40 kg or less - Your child's ASA status is 1 or 2 - Both parents or legal guardians have given consent You may NOT be eligible if: - Your child is under 2 or over 10 years old - Your child weighs more than 40 kg - The surgery is an emergency or unscheduled procedure - Your child is having ear, nose, throat (ENT), or esophageal/stomach surgery - Your child has a history of GERD, esophageal disease, or prior esophageal surgery - Your child has childhood obesity - Your child has had a tracheostomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMAVEPPIC: 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