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临床试验/NCT06469580
NCT06469580招募中不适用

Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure in Term and Preterm Neonates- a Randomized Controlled Pilot Trial

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024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
招募中
发起方
入组人数
40
试验地点
2
主要终点
Reintubation rate (within 72 hours after extubation)

研究概览

简要总结

The objective of the study is to evaluate the role of neonatologist-performed lung ultrasound (NPLUS) after weaning from invasive mechanical ventilation and extubation. Our aim is to study the diagnostic accuracy of NPLUS and investigate whether LUS leads to earlier actions before clinical deterioration and hence prevents extubation failure.

详细描述

In the past few years, lung ultrasound has been established as a tool to dynamically assess the lungs in various clinical conditions. Standardized protocols have been compiled to allow for an easy and fast evaluation. The point-of-care ultrasound (POCUS) is easily accessible and allows the clinician a readily available bed-side evaluation.

Although invasive mechanical ventilation displays a lifesaving strategy in neonatal intensive care, it is associated with numerous long-term complications especially in preterm infants. Despite a shift to lung-protective ventilation, time on mechanical ventilatory support should be kept as short as possible, considering timely weaning and switch to a non-invasive ventilation. Estimating the right time for discontinuation of invasive mechanical ventilation remains challenging and is influenced by several parameters. Extubation failure can be associated with respiratory failure following exhaustion on non-invasive ventilatory support.

Collapse of alveolar units lead to hypo-aerated areas. Small airway size, obstruction due to secretion and muscular weakness predispose to the development of atelectasis in neonates. Atelectasis occurring post extubation are a frequent cause of extubation failure. Lung consolidations can be sonographically detected. A sensitivity of 100% for the detection of neonatal pulmonary atelectasis has been described. In recent studies Lung Ultrasound Severity Score (LUSS) has been shown to be an independent predictor of successful extubation in mechanically ventilated preterm infants. However, once extubated, only limited data is available if extubation failure later in the process can be predicted. Lung aeration decreased after extubation to spontaneous breathing.

Early standardized evaluation of the lung via lung ultrasound can deliver important information on aeration of the lungs and whether action may be required. Using a standardized protocol (lung ultrasound score, LUS) on certain timepoints after extubation can lead to early detection of loss of aeration. Timely intervention with e.g., temporary PEEP increase for alveolar recruitment on non-invasive ventilatory support, positioning of the patient prior to clinical deterioration can impede the need of a reintubation and invasive mechanical ventilatory support.

研究设计

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

入排标准

年龄范围
1 Minute 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm and full-term neonates receiving invasive mechanical ventilation at the Division of Neonatology of the Medical University of Graz AND
  • Written informed consent was obtained from parents prior to extubation

排除标准

  • 未提供

研究组 & 干预措施

control group

No Intervention

Includes routine care in the control group in case of clinical (respiratory) deterioration which is optional chest x-ray or NPLUS at any time point after extubation indicated by the clinician in charge. There are no study-specific measures in the control group.

NPLUS group

Experimental

In the NPLUS group (intervention group) lung ultrasound is performed at time point T0 (prior to extubation), T1 (2-4 hours post extubation) and time point T2 (16-24 h) post extubation.

干预措施: NPLUS (neonatologist performed lung ultrasound) (Other)

结局指标

主要结局

Reintubation rate (within 72 hours after extubation)

时间窗: within 72 hours after extubation

次要结局

  • Mode of respiratory support(within 72 hours after extubation)
  • Respiratory settings- FiO2(within 72 hours after extubation)
  • Number of lung imaging based interventions(within 72 hours after extubation)
  • Time to detect consolidations(within 72 hours after extubation)
  • Lung ultrasound scores (LUS)(up to 24 hours after extubation)
  • Respiratory settings- PEEP(within 72 hours after extubation)
  • Carbon dioxide partial pressure (pCO2)(within 72 hours after extubation)
  • SpO2/FiO2 ratio(every hour during 72 hours after extubation)
  • pH from capillary blood gas analysis(within 72 hours after extubation)
  • Number of lung imaging(within 72 hours after extubation)
  • Recruitment maneuvers(within 72 hours after extubation)
  • Base Excess (BE)(within 72 hours after extubation)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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