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临床试验/NCT03978221
NCT03978221Unknown不适用

Diaphragm Performance Evaluation With Tissue Doppler Ultrasound Examination During Spontaneous Breathing in Facial Mask and During Non-invasive Ventilation in the Post-extubation Period.

Azienda Ospedaliero Universitaria Maggiore della Carita2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
diaphragmatic displacement velocity

研究概览

简要总结

The aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration.

this analysis will be performed through diaphragmatic tissue Doppler assessment.

详细描述

Early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. Moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation.

The diaphragmatic tissue doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. It can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive.

The aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes.

Method Patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet NIV.

Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration.

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

  • invasive mechanical ventilation > 24h with consequent extubation

排除标准

  • refusal to grant consent
  • pregnancy
  • age >18 years
  • haemodynamic instability
  • difficult management of secretions
  • required inotropic and / or vasoactive drugs at high doses

研究组 & 干预措施

diaphragmatic tissue doppler evaluation

Experimental

A tissue Doppler evaluation, using a sectorial probe, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration randomly assessed in spontaneous breathing with Venturi Mask and in Non-invasive ventilation with a helmet or facial mask

干预措施: Post-extubation TDI (Other)

结局指标

主要结局

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 NIV trial and in spontaneous breathing with Venturi mask.

次要结局

  • Diaphragmatic acceleration(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 minutes)
  • Dyspnea level(through each trial completion, an average of 20 minutes)
  • Comfort level(through each trial completion, an average of 20 minutes)
  • Hemodynamic parameters, Heart Rate (HR)(athrough each trial completion, an average of 20 minutes)
  • Blood Pressure (BP)(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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