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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Vittore Buzzi Children's Hospital
Contact Anna Camporesi, M.D.
Phone +393355793744
Email anna.camporesi@asst-fbf-sacco.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electrical Impedance Tomography
Measure of regional ventilation by Electrical Impedance Tomography (EIT) before and during pneumoperitoneum

Locations

Country Name City State
Italy Vittore Buzzi Children's Hospital Milano

Sponsors (1)

Lead Sponsor Collaborator
Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

Outcome

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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