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临床试验/NCT03557905
NCT03557905已完成不适用

Ultrasonographic Assessment of Lung Recruitment Maneuvers in Pediatric Patients Undergoing Lengthy Microsurgery Operations

Assiut University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年8月6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
44
试验地点
2
主要终点
Lung Areation Score

研究概览

简要总结

The aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).

详细描述

  • To maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. Several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound.
  • For lung CT examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. The oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive.
  • Using lung ultrasound (LUS) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children.
  • LUS can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.

研究设计

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

盲法说明

Ventilator adjustments, lung recruitment, PEEP titration and ultrasonographic assessments will be done by well-trained investigators not involved in data collection. The surgeon, the parents or legal guardians and the data collection personell will be blinded to the patients' group assignment.

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 2-12 years old.
  • ASA physical status classification I-II.
  • Undergoing lengthy microsurgery operations
  • and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.-

排除标准

  • ASA Physical status classification >II.
  • Thoracic or abdominal surgery.
  • Preexisting lung disease.
  • Pre-operative chest infection or abnormal chest US findings.
  • Cardiac patients.-

结局指标

主要结局

Lung Areation Score

时间窗: 10 minutes after induction of anesthesia

lung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.

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

Hala Saad Abdel-Ghaffar

Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Assiut University

研究点 (2)

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