Paratracheal compression during mask ventilation 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
This trial will test whether pressing beside the windpipe during mask ventilation stops air from entering the stomach in children having elective surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 2 sites (Lille and 1 other locations) |
| Trial ID | NCT05279170 on ClinicalTrials.gov |
What this trial studies
This interventional study applies paratracheal compression during mask ventilation in children aged 2–10 undergoing elective surgery after inhalation induction. Clinicians will deliver the maneuver while monitoring for gastric insufflation using echography and airway pressure measurements. The procedure is proposed as an alternative to cricoid pressure, with excluded patients including those with esophageal disease, prior esophageal surgery, obesity, or planned ENT/esogastric operations. Safety and effectiveness outcomes will be collected during the perioperative period.
Who should consider this trial
Good fit: Children aged 2 to 10 years who are ASA 1–2, undergoing elective surgery with inhalation induction, and whose parents/legal guardians provide consent are ideal candidates.
Not a fit: Children under 2 or over 10 years, those with BMI-for-age obesity, ASA ≥3, esophageal disorders or prior esophageal surgery, scheduled ENT/esogastric procedures, predicted difficult mask ventilation, or without social health insurance are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the maneuver could reduce gastric insufflation and lower the risk of regurgitation or aspiration during mask ventilation in children.
How similar studies have performed: Similar paratracheal compression techniques have shown effectiveness in adults to prevent gastric insufflation, but this maneuver has not yet been evaluated in the pediatric population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille and 1 other locations
- Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique — Lille, France (Recruiting)
- Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique — Lille, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.