Paratracheal compression during mask ventilation 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
Run by University Hospital, Lille · NCT05279170 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 10 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 2 sites (Lille and 1 other locations) |
| Status | Recruiting |
| Started | June 6, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT05279170 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France Recruiting -
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.