Assessing lung ventilation in healthy children under anesthesia
Changes in Pulmonary Ventilation Distribution Assessed by EIT (Electrical Impedance Tomography) in Healthy Children Under General Anesthesia; a Pilot Study Comparing Mask Spontaneous Breathing and Laryngeal Mask Spontaneous Breathing With and Without Ventilatory Support
This study tests how different breathing methods during anesthesia affect lung function in healthy children aged 1 to 6 years who are having elective circumcision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Queen Fabiola Children's University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06262360 on ClinicalTrials.gov |
What this trial studies
This study investigates how different ventilation methods during general anesthesia affect lung ventilation distribution in healthy children aged 1 to 6 years undergoing elective circumcision. It compares spontaneous mask ventilation and laryngeal mask ventilation using electrical impedance tomography to assess the incidence of atelectasis and its impact on oxygenation. The children will be divided into three groups to evaluate the effectiveness of each ventilation method. The study aims to enhance understanding of pulmonary dynamics in pediatric anesthesia.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 1 to 6 years, classified as ASA physical status I or II, scheduled for elective circumcision.
Not a fit: Patients with a history of lung diseases, congenital heart diseases, or other conditions affecting lung dynamics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve anesthesia practices and reduce post-operative pulmonary complications in children.
How similar studies have performed: While there is limited research directly comparing these ventilation methods in pediatric patients, the use of electrical impedance tomography in assessing lung function is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children undergoing elective circumcision * Age 1 to 6 years * ASA class I or II Exclusion Criteria: * Any history of lung diseases, congenital heart diseases or abdominal diseases that could interfere with lungs dynamic. * ASA physical status11 \> II. * Patients whose weight is less than 10 kg. * The use of Jackson-Rees device12. * Contraindication for premedication. * Contraindication for mask ventilation or laryngeal mask ventilation13. * Contraindication for regional anesthesia. * Need for opioids administration during surgery. * Patients with uncontrollable movements of the body. * Inability of parents/tutors to understand French or Dutch. * Patients whose parents do not agree with their participation in the study * Patients with thoracic perimeters (between 4th and 6th ribs) less than 37.5 cm (minimal size for the pediatric EIT belt) or more than 72 cm (maximal size for the pediatric EIT belt) * Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings. * Patients with spinal lesions or fractures (acute or recent) * Patients with pacemaker, defibrillators, or other electrically active implants
Where this trial is running
Brussels
- H.U.B - Hôpital Universitaire des Enfants Reine Fabiola — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Denis Schmartz, MD
- Email: denis.schmartz@hubruxelles.be
- Phone: +3225553919
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.