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临床试验/NCT06214312
NCT06214312已完成不适用

Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway: a Randomized Double-Blinded Controlled Trial That Compares Spontaneous and Pressure Support Ventilation

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Pulmonary aeration

研究概览

简要总结

This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.

详细描述

It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.

Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air >96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.

排除标准

  • ASA score > II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.

结局指标

主要结局

Pulmonary aeration

时间窗: during surgery and in the immediate postoperative period

Compare the Lung Aeration Score in the two groups

次要结局

  • Ventilatory parameters(during surgery)
  • Plethysmography(during surgery and in the immediate postoperative period.)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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