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临床试验/NCT03962322
NCT03962322已完成不适用

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Azienda Ospedaliero Universitaria Maggiore della Carita2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月27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
100
试验地点
2
主要终点
Primary Outcome Measure - Change in diaphragmatic displacement velocity

研究概览

简要总结

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

详细描述

Tobin Index (RSBI), which is the ratio between respiratory rate (RR) and tidal volume (VT), is one of the most used indices to predict weaning outcome. The diaphragm plays a key role in generating VT and, in the case of diaphragmatic dysfunction, inspiratory accessory muscles may contribute to support ventilation. If this occurs during a spontaneous breathing trial (SBT), it will probably result in delayed weaning, since the accessory muscles are more fatigable than the diaphragm.

The diaphragmatic tissue Doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of heart's motility. Being a muscle doppler assessment, it can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive, as well as other derived index of muscle function.

The aim of the study is to measure the variations of diaphragmatic displacement velocities before and during the spontaneous breathing trial, useful to check if the patient is ready to breathe spontaneously. An observational study will be performed. Patients who are ready to be weaned will be subjected to a spontaneous breathing test (Cpap 5), that consists of applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes. A tissue Doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration in the modality of ventilation which precedes the trial and during the SBT.

Vital parameters will be monitored during the study. Mechanical ventilation length, incidence of tracheostomies, ICU and hospital recovery duration and hospital mortality will also be acquired.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • mechanical invasive ventilation ≥ 24 h
  • readiness for extubation

排除标准

  • refusal to grant consent
  • pregnancy
  • hemodynamic instability
  • difficult management of secretions
  • request for inotropy and/or vasoactive drugs at high doses

结局指标

主要结局

Primary Outcome Measure - Change in diaphragmatic displacement velocity

时间窗: through each trial completion, an average of 20 minutes

Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial ( CPAP 5 ) and in spontaneous breathing.

次要结局

  • Diaphragmatic acceleration and deceleration(through each trial completion, an average of 20 minutes)
  • Gas exchange - arterial carbon dioxide tension(through each trial completion, an average of 20 minutes)
  • Gas exchange - pH(through each trial completion, an average of 20 minutes)
  • Gas exchange - arterial oxygen tension(through each trial completion, an average of 20 min)
  • Dyspnea level(through each trial completion, an average of 20 minutes)
  • Heart rate(through each trial completion, an average of 20 minutes)
  • Number of patients who experienced weaning failure(over 48 hours following extubation)
  • Blood Pressure(through each trial completion, an average of 20 minutes)

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianmaria Cammarota

Principal Investigator, MD of ICU staff

Azienda Ospedaliero Universitaria Maggiore della Carita

研究点 (2)

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