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临床试验/NCT05777018
NCT05777018已完成不适用

Safety and Efficacy of Ultrasound Guided Lung Recruitment Maneuvers for Prevention of Postoperative Atelectasis After Pediatric Laparoscopic Abdominal Surgery: A Prospective Randomized Study

Tanta University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
The incidence of atelectasis

研究概览

简要总结

In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration. The mass of the abdominal organs pushes the diaphragm cranially compressing the lungs in the most dependent areas. Such regional lung collapse may range from a slight loss of aeration to complete atelectasis.

详细描述

A wide variety of recruitment maneuvers has been described. The most relevant are represented by sustained inflation maneuvers, high pressure-controlled ventilation, incremental PEEP, and intermittent sighs. However, the best recruitment maneuver technique is currently unknown and may vary according to the specific circumstances. The most commonly used recruitment maneuver is the sustained inflation technique, in which a continuous pressure of 40 cm H2O is applied to the airways for up to 60 seconds. Sustained inflation has been shown to be effective in reducing lung atelectasis, improving oxygenation and respiratory mechanics, and preventing endotracheal suctioning-induced alveolar derecruitment. However, the efficacy of sustained inflation has been questioned and other studies showed that this intervention may be ineffective, short-lived, or associated with circulatory impairment, an increased risk of baro/volutrauma, a reduced net alveolar fluid clearance, or even worsened oxygenation.

Lung ultrasound has been gaining consensus as a noninvasive, radiation-free tool for diagnosing various pulmonary diseases in adult and pediatric patients. Evidence supporting lung ultrasound use is expanding beyond emergency and critical care settings to perioperative care.

It has been reported that lung ultrasound (LUS) at a patient's bedside immediately following surgery can be useful for diagnosing respiratory complications. LUS has been proven to be a valuable bedside diagnostic tool for pneumothorax, with high sensitivity and specificity (78.6% and 98.4%, respectively), and a higher rate of detecting abnormalities such as lung alveolar consolidation and pleural effusion than bedside chest X-ray or physical examination. LUS has also been used to diagnose anesthesia-induced atelectasis in pediatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for laparoscopic abdominal surgery
  • American Society of anaesthesiologist class I & II

排除标准

  • Pre-existing cardiac disease.
  • Morbidly obese patients according to age.
  • Patients with previous thoracic or cardiac surgery.
  • Upper or lower airway infection within 2 weeks before the surgery.
  • Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion.
  • Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia.
  • Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.

结局指标

主要结局

The incidence of atelectasis

时间窗: postoperative first 2 hours

The incidence of atelectasis in post anesthesia care unit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

tarek abdel hay mostafa

principle investigator

Tanta University

研究点 (2)

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