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临床试验/NCT03956511
NCT03956511已完成不适用

Integrated Prediction of Extubation Outcome by the Spontaneous Breathing Trial in Newborn Infants

Ourania Kaltsogianni1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Reintubation within 72 hours from extubation

研究概览

简要总结

Prolonged mechanical ventilation (MV) is associated with significant adverse effects in newborn infants and clinicians aim at its minimum possible duration. Failed extubation and need for reintubation is common and further prolongs the duration of MV. Hence, accurate prediction of readiness for extubation would incur a considerable reduction in respiratory morbidity.

The Spontaneous breathing Trial (SBT) involves placing the infant on endotracheal continuous positive airway pressure for five minutes with continuous monitoring of heart rate and oxygen saturation levels. The infant would pass the test if there is no hypoxia or bradycardia during the trial. A successful SBT might predict successful extubation.

The respiratory muscles play a crucial role in successful extubation. One simple way to quantify respiratory muscle function is the rate of relaxation of the inspiratory muscles that can be depicted by the rate of the decline of the airway pressure signal following a spontaneous breath.

The hypothesis of the investigator is that respiratory muscle function assessment using the rate of relaxation of the inspiratory muscles during a SBT can accurately predict extubation outcomes either independently or in conjunction with the outcome of the SBT and the variability of the respiratory parameters during the SBT. This could increase the predicting accuracy of extubation outcomes and thus reduce re-intubation associated respiratory morbidity.

详细描述

Prolonged endotracheal mechanical ventilation has significant adverse effects in newborn infants including subglottic stenosis, bacterial colonisation and bronchopulmonary dysplasia. Neonatal health professionals aim to limit the period of mechanical ventilation to the minimum possible duration. The decision to extubate is commonly a clinical one, based on current ventilator settings, blood gases analysis and the overall clinical condition of the infant. On the other hand, newborn infants commonly fail extubation and require reintubation which is a traumatic invasive procedure which could further prolong the total duration of invasive mechanical ventilation. Thus, accurate prediction of readiness for extubation outcome will probably incur a notable reduction in respiratory morbidity.

A number of studies have evaluated methods to predict extubation outcome. Of them, the spontaneous breathing trial (SBT) has been shown to hold the highest predictive value: it involves placing an infant from invasive mechanical pressure limited time cycled ventilation ventilation to endotracheal continuous positive end-expiratory pressure (ET-CPAP) for a period of 5 minutes during which saturation and heart rate are closely monitored. The infant would pass the test if there is no hypoxia or bradycardia during the test. A successful SBT has a positive predictive value of 93%, sensitivity of 97% and specificity of 73%. The combination of a successful SBT with increased variability in respiratory parameters during the SBT has been reported to further increase the sensitivity of the trial; alas the specificity remains below 75%.

It should be noted that at King's College Hospital the SBT forms part of routine clinical care as per clinical guideline and it is at the discretion of the attending physician to conduct the trial prior to extubation.

The work of breathing is undertaken by the respiratory muscles. Impaired respiratory muscle function is associated with a higher risk of respiratory muscle fatigue and respiratory failure and need for mechanical ventilation. Respiratory muscle function has been identified as an independent predictor of extubation outcome in mechanically ventilated infants. One simple way to quantify respiratory muscle function is the rate of relaxation of the inspiratory muscles which can be depicted by the rate of the decline of the airway pressure signal following a spontaneous breath. In concept, inefficient muscle function is manifested by a more gradual drop to baseline of the airway pressure over time. The principle on which the method is based is that when skeletal muscles contract against increased external loads, their relaxation slows as a result of slower calcium uptake by skeletal muscle fibres. In terms of physical properties, fatigued muscle fibres take longer to relax after contraction and this reduction in the relaxation rate can be quantified by an increase in the time constant of relaxation and a decrease in the maximal relaxation rate.

The rate of relaxation of the inspiratory muscles has been shown to accurately describe respiratory muscle function in non-neonatal populations. The information on the inspiratory muscle rate of relaxation is readily available in the ventilator graphics which, as part of routine clinical care, use a pressure port and a flow sensor to record airway flow, delivered volume and pressure over time. To the knowledge of the investigator, the potential value of this information in predicting extubation outcome in newborn infants has not been explored to date.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All infants with a planned extubation.

排除标准

  • Infants with known genetic or chromosomal abnormalities.
  • Infants with congenital anomalies other than Congenital Diaphragmatic Hernia or Anterior Wall Defect and
  • Infants with focal acute lung pathology such as atelectasis or pneumothorax will be excluded from the study.

结局指标

主要结局

Reintubation within 72 hours from extubation

时间窗: Through study completion, an average one year

Reintubation will be assessed by reviewing infant's clinical records

次要结局

  • Comparison of the rate of relaxation of respiratory muscles between premature infants that fail extubation and premature infants that successfully wean off mechanical ventilation.(Through study completion, an average one year)
  • Comparison of the rate of relaxation of respiratory muscles between premature infants and term infants.(Through study completion, an average one year)

研究者

发起方
Ourania Kaltsogianni
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ourania Kaltsogianni

Dr Ourania Kaltsogianni, MSc Advanced Paediatrics

King's College Hospital NHS Trust

研究点 (1)

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