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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilation; Pediatric Anesthesia; Laparoscopy
• Intervention / Treatment: Device: Electrical Impedance Tomography

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Anna Camporesi, M.D.; Phone Number: +393355793744; Email: anna.camporesi@asst-fbf-sacco.it

Study Locations

• Italy
  • Milano, Italy, 20154
    • Recruiting
    • Vittore Buzzi Children's Hospital
    • Contact: Anna Camporesi, M.D.; Email: anna.camporesi@asst-fbf-sacco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients age 10-18 undergoing laparoscopic procedures

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Ventilation distribution	Difference in regional ventilation distribution before and after institution of pneumoperitoneum	Intraoperative

Collaborators and Investigators

• Sponsor: Vittore Buzzi Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 8, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EITPEDLAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No