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临床试验/NCT05539599
NCT05539599已完成不适用

Can Heart-lung-respiratory Muscles Ultrasound Evaluation Play a Role to Predict Weaning in Critically Ill Patients?

Università degli Studi di Ferrara2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2022年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
Assessing the prognostic value of a combined score in predicting weaning success

研究概览

简要总结

Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Indeed, unresolved lung disease, cardiac dysfunction, loss of respiratory and core muscle strength can play a role in a failure weaning to mechanical ventilation (MV). The investigators hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success. Furthermore, it will be described weather the days of MV before weaning trial may affect the relevance of each clinical variable evaluated.

详细描述

Critically ill patients undergone at least 48 hours of MV and ready to spontaneous breathing trial (SBT) will be included in the study. The spontaneous breathing trial is performed in pressure support ventilation with a clinician-set positive end expiratory pressure (PEEP) ≤ 5 cm H2O and FiO2< 40%. In addition to the parameters traditionally used for the evaluation of weaning (RSBI), the investigators will perform ultrasound evaluation of diaphragm, lung parenchyma, cardiac function, and the strength of the hand grip.

Investigators will evaluate the diaphragmatic parameters (thickening fraction,TF, and diaphragmatic displacement, DD) and TFmax (TF during forced breathing /TF during tidal respiration) to identify the inspiratory reserve. Weaning success is considered as liberation from MV within 72 hours.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 18 and 90 years
  • Mechanical ventilation> 48 h
  • Reason for ICU admission: medical / surgical / trauma

排除标准

  • age under 18
  • diagnosis of neuromuscular disease
  • tracheostomy
  • terminal extubation
  • pregnancy in progress -
  • previous paralysis of the diaphragm or of a hemidiaphragm
  • use of neuromuscular blocking drugs in continuous infusion in the 48 hours preceding the weaning attempt.
  • Refusal to participate in the study

结局指标

主要结局

Assessing the prognostic value of a combined score in predicting weaning success

时间窗: 72 hours

We hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success.

次要结局

  • Interaction between days of mechanical ventilator and determinant of weaning success(28 days)

研究者

发起方
Università degli Studi di Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Fogagnolo

Principal investigator

Università degli Studi di Ferrara

研究点 (2)

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