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临床试验/NCT07073105
NCT07073105已完成不适用

Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee

Ain Shams University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
reproducibility of results between CXR , expert and trainee tracheal ultrasound

研究概览

简要总结

Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position .

This study will compare the effectiveness of endotracheal tube position obtained by ultrasonography vs that obtained by chest X-ray with two operators an expert and a trainee in preterm neonates.

This study will work to the extent that the trainee has the ability to do sonar for premature babies with the same efficiency as an ultrasound specialist.

详细描述

neonate in the neonatal intensive care unit (NICU) are intubated for different reasons and most of these patients undergo chest X-rays (CXRs) several times during their ICU admission to confirm endotracheal tube (ETT) placement, monitor severity of cardiopulmonary illness, and detect complications of other indwelling devices Although the amount of radiation exposure is minimal with CXRs, exposure to multiple CXRs in NICU patients, especially in preterm, results in accumulated radiation burden over time. This can lead to tissue damage and is associated with an increased risk of malignancy Tracheal ultrasonography is technique for confirmation of proper endotracheal intubation. Potential advantages include detection of both main stem and esophageal intubation and less time to image availability than CXR and less radiation Point of care ultrasound (POCUS) of the anterior neck is increasingly used by emergency physicians and anesthesiologists to detect endotracheal and esophageal intubation. It is more accurate and faster than physical examination and capnography, with adult meta-analyses reporting that it has sensitivities of 93-98%, specificities of 97-98% We will explore effectiveness and reproducibility of tracheal ultrasonography done by in hospital neonatologist trainee in the technique vs the expert radiologist in determination of ET position.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Hour 至 30 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Less than 35weeks gestational age
  • •Invasive mechanical ventilation via ETT.

排除标准

  • •Upper air way anomalies.
  • •eligible patients whose care team deemed enrollment will disrupt patient care.

研究组 & 干预措施

confirmation of ETT by CXR

Active Comparator

confirmation of ETT site by CXR the gold standard

干预措施: Chest x-ray (Diagnostic Test)

ETT site confirmation by trainee tracheal ultrasound

Experimental

confirmation of ETT site was done by tracheal ultrasound performed by a trainee neonatologist after receiving training for the procedure

干预措施: tracheal ultrasound by trainee neonatologist (Diagnostic Test)

ETT site confirmation by expert tracheal ultrasound

Experimental

confirmation of ETT tube site by expert radiologist performing tracheal ultrasound

干预措施: tracheal ultrasound ( expert radiologist) (Diagnostic Test)

结局指标

主要结局

reproducibility of results between CXR , expert and trainee tracheal ultrasound

时间窗: 24 hours

Accuracy of the findings of the tracheal ultrasound by expert, trainee and chest x ray for the same patient

time in minutes to receive tracheal ultrasound by expert radiologist results for ETT site

时间窗: 24 hours

Time taken from giving order to perform the tracheal ultrasound by expert radiologist to receiving the results of the imaging

time in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site

时间窗: 24 hours

Time taken from giving order to perform the tracheal ultrasound by trainee neonatologist to receiving the results of the imaging

time in minutes to receive CXR results for ETT site

时间窗: 24 hours

Time taken from giving order to perform chest x ray to receiving the results of the imaging

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

Mariam Ibrahim

Assistant Professor of paediatrics and neonatology , Ain shams University

Ain Shams University

研究点 (1)

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