Laparoscopy Clinical Trial
— PulmopneumoOfficial title:
Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy: an Observational Study
NCT number | NCT05823688 |
Other study ID # | EITPEDLAP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | December 31, 2024 |
The goal of this prospective, observational study is to describe EIT measurements at different time points during the perioperative period in healthy children undergoing laparoscopic surgery. The objective is to evaluate the impact of general anesthesia and laparoscopy on regional pulmonary ventilation visualized at EIT during the perioperative period.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | Vittore Buzzi Children's Hospital | Milano |
Lead Sponsor | Collaborator |
---|---|
Vittore Buzzi Children's Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regional Ventilation distribution | Difference in regional ventilation distribution before and after institution of pneumoperitoneum | Intraoperative |
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