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临床试验/NCT04107090
NCT04107090已完成不适用

Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level

Ain Shams University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年1月20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 ultrasound guided recruitment maneuver and the total number of NICU admission days.

研究概览

简要总结

This work is designed to:

  1. Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
  2. Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.

详细描述

The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission:

Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography.

Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.

Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Hour 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age ≤ 36 weeks.
  • In need for invasive mechanical ventilation for RDS according to Downes Score .

排除标准

  • excluded:
  • Major upper or lower airway anomalies.
  • Significant congenital anomalies including cardiac, abdominal or respiratory.
  • Surgical cases
  • Inborn errors of metabolism
  • Early onset sepsis.
  • Meconium aspiration syndrome.
  • Hypoxic ischemic encephalopathy.

结局指标

主要结局

Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.

时间窗: 1 year

The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .

Lung ultrasound and recruitment maneuver

时间窗: 1 year

An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C).

Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.

时间窗: 1 year

The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .

Lung ultrasound and diagnosis of respiratory distress syndrome

时间窗: 1 year

Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation.

Lung ultrasound guided recruitment maneuver and its relation to lung inflammation

时间窗: 1 year

Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day.

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

Dina Reda Fikry Kamel

Assistant Lecturer

Ain Shams University

研究点 (2)

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