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临床试验/NCT05823688
NCT05823688招募中不适用

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

Vittore Buzzi Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Regional Ventilation distribution

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA Status I and II
  • elective or urgent laparoscopic procedures (e.g., appendectomy, cholecystectomy, varicocelectomy)

排除标准

  • 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)

结局指标

主要结局

Regional Ventilation distribution

时间窗: Intraoperative

Difference in regional ventilation distribution before and after institution of pneumoperitoneum

次要结局

未报告次要终点

研究者

发起方
Vittore Buzzi Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Camporesi

Principal Investigator

Vittore Buzzi Children's Hospital

研究点 (1)

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