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RecruitingNCT05823688

Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy

Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy: an Observational Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Vittore Buzzi Children's Hospital · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers

Summary

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.

Detailed description

Electrical impedance tomography (EIT) is a non-invasive, radiation-free functional imaging technique based on image reconstruction of pulmonary regional ventilation by estimating the changes in resistivity (impedance) that occur in the lungs during respiration. Validation data confirms that EIT is highly reproducible and that impedance changes accurately reflect changes in regional ventilation. This allows for the derivation of EIT-derived measurements that can be used to assess bedside regional lung function. In clinical practice there is increasing emphasis on understanding the impact of anesthesia and mechanical ventilation on regional pulmonary ventilation in order to improve clinical outcomes, including in children. Several studies have demonstrated that the benefits of using EIT to set ventilatory parameters, improving gas exchange and respiratory mechanics are also applicable outside the intensive care unit. For example, monitoring of changes in regional ventilation in the operating room in adults has been studied to guide intraoperative ventilation setting and adopt it as a strategy to prevent anesthesia-induced atelectasis. The impact on regional pulmonary ventilation distribution may be significant in situations such as laparoscopic surgery, where capnoperitoneum and Trendelenburg position pose an additional risk of deterioration of respiratory function and may contribute to the development of early postoperative pulmonary complications.In the adult population, studies demonstrate that pneumoperitoneum during laparoscopy can influence the distribution of ventilation together with anesthesia and mechanical ventilation in different ways. In contrast, regional ventilation changes during laparoscopy are still lacking for the pediatric population. The aim of the present study is to investigate how general anesthesia and capnoperitoneum during laparoscopic procedures can affect the distribution of regional ventilation displayed by EIT in healthy pediatric patients and how these changes correlate with ventilatory parameters and clinical outcomes.

Conditions

Interventions

TypeNameDescription
DEVICEElectrical Impedance TomographyMeasure of regional ventilation by Electrical Impedance Tomography (EIT) before and during pneumoperitoneum

Timeline

Start date
2023-05-01
Primary completion
2024-06-30
Completion
2024-12-31
First posted
2023-04-21
Last updated
2024-05-10

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05823688. Inclusion in this directory is not an endorsement.