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临床试验/NCT03978221
NCT03978221
Unknown
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 Carita1 个研究点 分布在 1 个国家目标入组 20 人2019年4月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Acute Respiratory Failure
发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
入组人数
20
试验地点
1
主要终点
diaphragmatic displacement velocity
最后更新
6年前

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. Inclusion criteria: invasive mechanical ventilation \> 24h with consequent extubation. Exclusion criteria: refusal to grant consent, pregnancy, age \< 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses. During the study, vital parameters will be given.

注册库
clinicaltrials.gov
开始日期
2019年4月1日
结束日期
2020年4月1日
最后更新
6年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
责任方
Principal Investigator
主要研究者

Gianmaria Cammarota

Principal Investigator, MD of ICU staff

Azienda Ospedaliero Universitaria Maggiore della Carita

入排标准

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

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)

研究点 (1)

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