Effect of Sustained Inflations on Lung Atelectasis During Pediatric Laparoscopic Surgery as Determined by Lung Ultrasound: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The lung aeration score by ultrasound
研究概览
简要总结
The aim of our study is to assess the beneficial effect of sustained inflations as a recruitment manoeuvre, using LUS examinations, on the degree of lung atelectasis that occurs in pediatric patients undergoing laparoscopic surgery.
Objectives
- To assess the effect of general anaesthesia and capnoperitoneum on lung atelectasis in the paediatric patients by using LUS examination
- To assess the effect of sustained inflations as a recruitment manoeuvre in decreasing lung atelectasis caused by general anaesthesia and capnoperitoneum by using LUS examination
Hypothesis Our main hypothesis is that the use of repeated Sustained Inflation as a recruitment manoeuvre in pediatric patients undergoing laparoscopic surgery will result in decreased atelectasis compared to conventional ventilation.
详细描述
Our study will be conducted in Cairo University Specialized Pediatric Hospital (Abo El Reesh Hospital), after approval of the research ethical committee. An informed signed parental consent will be obtained from all study participants before their enrolment in the study. recruitment of cases will be started after registration in clinicaltrials.gov and getting unique number
Methodology
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Study Design Prospective Randomised Controlled Study
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Study Setting and Location The study will be conducted in the operating theatres at Cairo University Specialized Pediatric Hospital (Abo El Rich Hospital), Faculty of Medicine, Cairo University.
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Study Population 40 pediatric patients undergoing laparoscopic surgery will be included in the study. The patients will be randomly allocated into one of the two study groups; 20 patients per group.
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
- Single (Investigator)
盲法说明
lung ultrasound will be done by same doctor in both groups who is trained in lung ultrasound he will enter operating room only during ultrasound examination. not to know sustained inflations done in which cases
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Parental Consent
- •Scheduled for undergoing abdominal laparoscopic surgery
- •American Society of Anaesthesiologists (ASA) physical status classification Ⅰ-Ⅱ
排除标准
- •Emergency and thoracic procedures
- •Significant pre-existing pulmonary, cardiac or chest wall diseases
- •Abdominal distension
- •Acute airway infection
- •Previous thoracic procedure
结局指标
主要结局
The lung aeration score by ultrasound
时间窗: from start of surgery till half an hour postoperative
Four Lung ultrasound patterns were defined according to the degree of B lines: (0) fewer than three isolated B lines; (1) multiple well defined B lines; (2) multiple coalescent B lines and (3) white lung. The sum of the points obtained in all the 12 lung areas will constitute the lung aeration score, ranging from 0-36 for the whole thorax. This score is inversely proportional to the degree of lung aeration and directly proportional to the degree of lung atelectasis.
次要结局
- Incidence of hemodynamic instability or oxygen desaturation(from start of surgery till half an hour postoperative)
研究者
Ahmed Hussein Sayed Hasan
lecturer of anesthesia , surgical ICU and pin managment
Cairo University