Monitoring lung ventilation in children during laparoscopic surgery
Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy: an Observational Study
This study is testing how a special imaging technique can help doctors see how well healthy children’s lungs are working during laparoscopic surgery under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Vittore Buzzi Children's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT05823688 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate regional pulmonary ventilation in healthy children undergoing laparoscopic surgery using Electrical Impedance Tomography (EIT). By measuring changes in lung resistivity during the perioperative period, the study seeks to understand how general anesthesia and laparoscopy affect ventilation. EIT is a non-invasive imaging technique that provides real-time insights into lung function, which could help optimize ventilation strategies and improve clinical outcomes. The study will track EIT measurements at various time points to assess the impact of surgical positioning and anesthesia on respiratory function.
Who should consider this trial
Good fit: Ideal candidates include healthy children classified as ASA Status I and II undergoing elective or urgent laparoscopic procedures.
Not a fit: Patients with ASA status III-IV, severe respiratory illnesses, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of ventilation management in pediatric patients, potentially leading to improved postoperative respiratory outcomes.
How similar studies have performed: Previous studies have shown that EIT can effectively guide ventilation settings in adults, suggesting potential applicability in pediatric populations, although this specific approach is less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA Status I and II * elective or urgent laparoscopic procedures (e.g., appendectomy, cholecystectomy, varicocelectomy) Exclusion Criteria: * Lack of parental consent * ASA status III-IV * Presence of peritonitis or other abdominal inflammatory process that could potentially interfere with spontaneous breathing ventilation * Need for immediate resuscitation maneuvers * Severe respiratory illness in the previous 4-6 weeks * Pre-existing chronic pulmonary conditions * Concomitant acute pulmonary conditions (e.g. pneumonia, pleural effusion) * Cardiac arrest * Skeletal deformities (e.g. rib cage malformations or scoliosis), neuromuscular diseases or cardiac conditions affecting respiratory mechanics * BMI \> 30 * Presence of implantable devices not compatible with EIT (such as pacemakers and implantable defibrillators)
Where this trial is running
Milan
- Vittore Buzzi Children's Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Anna Camporesi, M.D.
- Email: anna.camporesi@asst-fbf-sacco.it
- Phone: +393355793744
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.