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临床试验/NCT04957264
NCT04957264已完成不适用

Assessment of Extubation Readiness in Preterm Infants Using Chest Ultrasound

Mount Sinai Hospital, Canada1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年10月22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
45
试验地点
1
主要终点
Accuracy of chest ultrasound in Prediction of extubation readiness in neonates born at less than 28 weeks gestation.

研究概览

简要总结

Preterm infants are at high-risk for the negative implications of both prolonged mechanical ventilation and extubation failure. Pre-extubation assessments of lung parenchyma and diaphragmatic function of these infants can be useful adjunctive tool for prediction of extubation readiness.

The aim of this study is to assess the sensitivity and specificity of lung ultrasound and diaphragmatic function evaluation in prediction of extubation readiness in mechanically ventilated neonates born at < 28 weeks gestational age.

详细描述

Study Design and setting:This is a prospective descriptive pilot study that will be conducted on infants born at < 28 weeks gestation who meet eligibility criteria and are admitted to the Neonatal intensive care at Mount Sinai Hospital. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent.

Time of assessment: Parents of infants on invasive mechanical ventilation who are eligible for the study will be approached for consent. Once the decision made by attending physician to extubate the infant, Chest ultrasound (Lung ultrasound + diaphragmatic function assessment) will be done. Chest ultrasound will be done before next feeding to avoid any interference of a full stomach on diaphragmatic assessment.

Study procedure: Decisions about extubation will be as per the clinical judgment of the physician in-charge of the infant and will not in any way based on Chest ultrasound measurements. A lung ultrasound combined with diaphragmatic function assessment will be done by one of the investigators prior to extubation. The result of Chest ultrasound will be masked for the clinical team to avoid any influence of the Chest ultrasound result on the extubation decision. On the other hand, if the attending physician requests Chest ultrasound for the purpose of the ongoing clinical management or to help with making extubation decision then the result of the study will be disclosed to the physician and this infant will be excluded from the study.

A random sample of 20% of eligible infants will have lung ultrasound scoring and diaphragmatic function assessment done twice by 2 operators (with various levels of Chest ultrasound expertise). None of the operator will be aware of the result of Chest ultrasound done by the other operator for the same patient. Lung ultrasound severity score, diaphragmatic thickness fraction and diaphragmatic excursion will be calculated. Inter-rater agreement will be assessed using raw percentage of agreement (Pa), Cohen's and Kappa (κ), and G wet agreement coefficient (AC1). Intra-class correlation will be determined for variables with continuous measurements (mixed factorial design). High-resolution linear and curvi-linear ultrasound probes of 20-5 and 10-3 MegaHertZ will be used to assess lung ultrasound score and to measure diaphragmatic thickness and diaphragmatic excursion [amplitude] respectively using both B-mode and M-mode.

Lung ultrasound assessment technique: Chest ultrasound will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 4 points with the total score ranges from 0 to 24 which inversely correlating with lung aeration.

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
12 Hours 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Infants who are born at < 28 weeks Gestational Age,
  • Admitted to the neonatal intensive care at Mount Sinai Hospital
  • Receiving invasive mechanical ventilation.

排除标准

  • Infants who are born at >27 weeks Gestational Age,
  • On non-invasive mechanical ventilation
  • Infants having congenital or chromosomal abnormalities,
  • Infants intubated for < 12 hours
  • Infants who have neurological insult, pneumothorax, or under muscle relaxant.
  • If parents declined the consent.

结局指标

主要结局

Accuracy of chest ultrasound in Prediction of extubation readiness in neonates born at less than 28 weeks gestation.

时间窗: 2 year

Chest ultrasound will be performed prior to extubation and Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0-to-4 point will be given for each area. The minimum score = 0 point and the maximum score = 24 points. successful extubation was defined as remained extubated at day 3 post extubation

次要结局

  • Assess the Diaphragmatic Thickness Fraction and Diaphragmatic Excursion in preterm infants(2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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