跳至主要内容
临床试验/NCT05019313
NCT05019313Unknown不适用

Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient

Azienda Sanitaria-Universitaria Integrata di Udine1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
试验地点
1
主要终点
Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction

研究概览

简要总结

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization.

This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation.

Mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve COVID-19 respiratory failure cause.

Calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage.

Basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive.

Ultrasound is the best method for measuring diaphragmatic work. The aim of this study is to evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted to Intensive Care Unit (ICU) for acute respiratory failure and to record its function on weaning.

详细描述

Hypoxemic acute respiratory failure in COVID-19 patients often leads to necessity of intubation and mechanical ventilation support. Complications may be severe as Ventilator-Induced Lung Injury (VILI) and respiratory infections. Weaning process from mechanical ventilation is based on respiratory work reduction and mechanical support to allow patient's respiratory ability to recovery. Respiratory muscle strength give an important contribute. Ultrasound diaphragmatic evaluation is essential to evaluate patients respiratory capacity as diaphragm atrophy usually suggest a difficult process and weaning failure.

COVID-19 pneumonia represent a particular type of ARDS (acute respiratory distress syndrome), in which different mechanism such as interstitial edema and diffuse alveolar damage, ventilation-perfusion mismatch, intrapulmonary shunt play a role/attend The aim of this study is to assess diaphragmatic function in weaning from mechanical ventilation in patients affected from COVID-19 respiratory failure and his implications.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypoxemic respiratory failure in COVID-19 patients during intensive care unit hospitalization
  • Age> 18 years
  • Weaning by mechanical ventilation

排除标准

  • tracheostomy,
  • unstable clinical conditions;
  • agitation (Richmond Agitation-Sedation Scale (RASS)≥ + 2) or non-cooperation (Kelly Matthay scale ≥5);
  • more than two organ failure
  • consent refusal

结局指标

主要结局

Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction

时间窗: During weaning by mechanical ventilation before attempt of extubation

Right diaphragmatic thickening fraction is evaluated by positioning a linear ultrasound probe at the level of the midaxillary line (pointer oriented towards the axillary cavity). Patient is in the supine position. Inspiratory and expiratory measurements are made as M-mode images. Right diaphragmatic measurement is considered as a reference. .

次要结局

  • Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.(After weaning and eventually extubation)

研究者

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

Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Azienda Sanitaria-Universitaria Integrata di Udine

研究点 (1)

Loading locations...

相似试验