跳至主要内容
临床试验/NCT06072885
NCT06072885已完成不适用

Prospective Observational Evaluation of Perioperative Lung Ultrasound Scores in Laparoscopic Pediatric Surgeries

Istanbul University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月15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
40
试验地点
1
主要终点
Lung Ultrasound Score in T2 time point (After surgery finish, before extubation)

研究概览

简要总结

Laparoscopic surgeries require carbon-dioxide into the abdomen which may occasionally lead to atelectasis. The extent of this atelectasis is not well documented in peri-operative period although it has been extensively researched in critical care set up. In this study, it is aimed to observe the ultrasonographic condition of lungs in laparoscopic pediatric surgeries. The hypothesis was the Lung Ultrasound Scores would worsen in those surgeries by the end of the operation. Aged between 1-18 years pediatric patients who are scheduled for laparoscopic surgeries will be included in the study to observe the changes in the lung visuals throughout the operation. For that, after safe endotracheal intubation first ultrasonography will be performed for the first (T1) time, and the second ultrasonography will be performed once the surgery is finished and before extubation (T2). Lastly, the third evaluation will be performed after 30 minutes in post anesthesia care unit (T3). Lung Ultrasound Score (LUS) is calculated as follows: Both hemi-thoraxes are divided into 6 different zones, and depending on the number of B-lines, which happens due to aeration loss in lung tissue, every zone is scored. If there is no B-line, it is zero points. If the B-lines in the visual lower than 4, the area is scored as 1 point. The areas with B-lines more than 3 is scored as 2 points. Furthermore, if there is any disruption on the pleural face, then the area is scored as 3 points. Accordingly, the worst case scenario refers 36 points, meaning the less the points the better the lung aeration.

Primary outcome is defined as T2 LUS which will show the actual condition of at the end of the surgery. For that, T1 scores and T2 scores will be compared. The secondary outcomes include T3 LUS, (T3-T1)LUS, intraoperative hemodynamics, length of stay in Post Anesthesia Care Unite, postoperative aldrete scores for discharging to ward, and intraoperative ventilation variables.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Laparoscopic pediatric surgeries
  • Aged between 1-18 years

排除标准

  • Patients with Constitutional lung diseases
  • Patients with Heart failure
  • Patients with pulmonary hypertension

结局指标

主要结局

Lung Ultrasound Score in T2 time point (After surgery finish, before extubation)

时间窗: Up to 4 hours

LUS is a pragmatic calculation reflecting lung aeration. Thorax is divided into 12 areas, and in every one of them LUS is applied to observe the lung condition. For that, if there are B-lines less than 4 in one area, it is scored as 1 point. For the areas containing more than 3 B-lines, it is scored as 2 points, and if there is any distortion on the pleural line, it is scored as 3 points. The areas with no B-lines is scored as 0 points. Considering these details, lungs with best conditions will reflect 0 points whereas the worst condition lungs will reflect 36 points. T2 LUS will be compared to T1 LUS to observe possible significant change in lung condition.

次要结局

  • Lung Ultrasound Score in T3 time point (30 minutes after admission to post anesthesia care unit(Up to 4 hours)

研究者

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

Meltem Savran Karadeniz

MD, Assoc Prof

Istanbul University

研究点 (1)

Loading locations...

相似试验