Actively Recruiting
Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study
Led by University Hospital, Lille · Updated on 2025-12-26
72
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new way to prevent stomach air and reduce risk during positive pressure ventilation in children aged 2 to 10 years undergoing general anesthesia. This study focuses on a maneuver called paratracheal compression, which has shown promise in adults but has not yet been tested in children. The goal is to assess if this method can effectively prevent gastric insufflation and reduce the chance of gastric aspiration or regurgitation during surgery. The intervention involves applying pressure with two fingers on the left side of the neck, between the trachea and the sternocleidomastoid muscle, to compress the esophagus. The force used will be adjusted based on the child's weight, ranging from 10 to 15 newtons. Before the procedure, ultrasound will be used to check that nearby blood vessels are not significantly compressed to ensure safety. During the study, children will undergo ultrasound scans to detect air in the stomach after two minutes of ventilation and to verify the position of the esophagus. Researchers will also monitor breathing parameters to identify any difficulties caused by the maneuver. The study will last through the surgical procedure, with careful assessment of safety and effectiveness in reducing gastric air during anesthesia.
CONDITIONS
Brief Title
MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 10 years undergoing general anesthesia with or without intubation
- Elective surgery
- Inhalation induction
- ASA status 1 or 2
- Child's consent if able to express it
- Consent from both parents or legal guardians
- Socially insured
You will not qualify if you...
- Children under 2 years or over 10 years
- Body weight over 40 kilograms
- ASA status 3 or higher
- Emergency or unscheduled surgery
- Scheduled ENT or esogastric surgery
- History of esophageal achalasia or GERD
- History of esophageal surgery such as NISSEN
- Childhood obesity based on BMI for age and sex
- Predictable mask ventilation difficulties
- History of tracheostomy
- Child not insured by social security
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before the intervention
Duration - During surgery under general anesthesia
Participants undergo positive pressure ventilation with mask ventilation applying paratracheal pressure to prevent gastric insufflation during general anesthesia. Safety and efficacy measurements are taken during this procedure.
1 intervention visit coinciding with surgery
Trial Site Locations
Total: 2 locations
1
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
Actively Recruiting
2
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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