Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy
Launched by VITTORE BUZZI CHILDREN'S HOSPITAL · Apr 8, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a special technique called Electrical Impedance Tomography (EIT) to monitor how well children breathe during laparoscopic surgery, which is a minimally invasive procedure. The goal is to see how general anesthesia and the surgery itself affect breathing in different areas of the lungs in healthy children. The study is currently recruiting participants aged between 1 and 18 years who are scheduled for elective or urgent laparoscopic surgeries, such as removing the appendix or gallbladder.
To participate in the trial, children must be healthy enough to be classified as ASA status I or II, meaning they are not severely ill. However, children with certain health issues—like severe respiratory illnesses, serious heart problems, or those who have had recent surgery—are not eligible. If a child joins the study, they will have EIT measurements taken at various times around their surgery to help doctors understand how the procedure impacts their breathing. Parents will need to give consent for their child to be part of this research. This study could provide valuable insights into how to improve care for children undergoing similar procedures in the future.
Gender
ALL
Eligibility 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)
About Vittore Buzzi Children's Hospital
Vittore Buzzi Children's Hospital is a leading pediatric healthcare institution dedicated to advancing children's health through innovative clinical research and compassionate care. With a commitment to improving patient outcomes, the hospital conducts a range of clinical trials aimed at evaluating new therapies and treatment modalities for pediatric conditions. Its multidisciplinary team of experienced researchers and healthcare professionals collaborates closely with families to ensure that each trial aligns with the highest ethical standards and prioritizes the well-being of child participants. Through its research initiatives, Vittore Buzzi Children's Hospital strives to enhance the understanding and treatment of childhood diseases, contributing significantly to the field of pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported