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临床试验/NCT03561792
NCT03561792已完成不适用

Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation: Comparison With Traditional Rapid Shallow Breathing Index

Zagazig University2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年12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
106
试验地点
2
主要终点
weaning failure

研究概览

简要总结

Predicting successful discontinuation from mechanical ventilation has been a focus of interest to all critical care physicians . Various weaning indices have been investigated to optimize the weaning process. Among them, the rapid shallow breathing index (RSBI) has gained wide use but it have different sensitivities and specificities. By substituting tidal volume (VT) with diaphragmatic displacement (DD) in the calculation of RSBI a new index (the diaphragmatic rapid shallow breathing index DRSBI) was proposed and it was independently associated with weaning failure and its accuracy for predicting weaning outcome is expected to be superior to the traditional RSBI.

详细描述

The rapid shallow breathing index (RSBI), calculated from respiratory rate divided by tidal volume (RR/VT), is a well-known weaning index and one of the most clinical indices used to predict weaning outcome. However, it has some limitations in predicting weaning outcomes. Several previous studies have defined different sensitivities and specificities for RSBI less than 105 to predict weaning success which may lead to errors in predicting successful weaning.

On the other hand, Weaning failure is likely to occur if there is an imbalance between the load on the inspiratory muscles and their neuromuscular capacity, the imbalance between the mechanical load imposed on the diaphragm which is the major muscle of inspiration and its ability to cope with it. Therefore, evaluating the function of diaphragm before any weaning trial could be useful in predicting weaning outcome.

Bedside ultrasonography is an easy, fast, noninvasive, and accurate maneuver for evaluating diaphragmatic function. Diaphragmatic displacement (DD) reflecting the ability of diaphragm to produce force and subsequently tidal volume during inspiration and defined as displacement of less than 10 mm has been found to be a predictor of weaning failure among patients in medical ICUs.

Spadaro et al. proposed substituting VT with DD in the RSBI, and calculating diaphragmatic RSBI (DRSBI) would result in a more accurate predictive index than the traditional RSBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

盲法说明

The ICU team on charge takes the decision to continue spontaneous breathing trial (SBT) according to the local practice protocols which depends on the traditional RSBI (RSBI < 105 predicts successful weaning). The ICU team will not be allowed to know the results of diaphragmatic ultrasound.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient or relative acceptance
  • Mechanically ventilated for more than 48 hours
  • Ready to wean and at their first spontaneous breathing trial
  • meeting all weaning criteria

排除标准

  • history of any neuromuscular disease
  • diaphragmatic palsy
  • cervical injury
  • current chest trauma
  • thoracotomy for any reason
  • patients in whom neuromuscular blockers are used in the last 48 hours before the study
  • patients for whom aminoglycosides are prescribed during their course in ICU

研究组 & 干预措施

traditional RSBI

No Intervention

the decision to continue SBT depends on the traditional RSBI (RSBI < 105 predicts successful weaning)

Diaphragmatic RSBI

Experimental

diaphragm ultrasound was done to measure diaphragmatic displacement which is used to calculate DRSBI and The investigator takes the decision about SBT continuation based on the result of DRSBI (DRSBI < 1.3 predicts successful weaning)

干预措施: Diaphragm ultrasound (Other)

结局指标

主要结局

weaning failure

时间窗: 48 hours

weaning failure is the inability to maintain spontaneous breathing for at least 48 h, Patients who required reintubation or noninvasive positive pressure ventilation within 48 h of discontinuation of mechanical ventilation (MV) will be considered failed to wean

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sherif M. S. Mowafy

Lecturer of Anesthesia and Surgical Intensive Care

Zagazig University

研究点 (2)

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