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临床试验/NCT07082361
NCT07082361尚未招募不适用

The Use of Diaphragmatic Ultrasonography: Does It Change Mechanical Ventilation Weaning Decision and Predict Outcome in COPD Patient?

Tanta University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Number of patients with failed weaning trial

研究概览

简要总结

The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.

Primary outcome:

• Number of patients with failed weaning trial and need reintubation.

Secondary outcomes:

  • Time till extubation trial.
  • Ventilation free days after extubation less or more than 48h .
  • Number of Intensive care unit discharges.
  • Sensitivity and specificity of diaphragmatic assessment as a predictor of weaning.

详细描述

Chronic obstructive pulmonary disease is the fourth killer among all diseases worldwide. It can be prevented and treated, so it is an important public health challenge. Inspiratory muscle weakness has a great clinical association with Chronic obstructive pulmonary disease patients. The prolonged mechanical ventilation and weaning failure may be related to diaphragmatic muscle dysfunction. The traditional weaning parameters (e.g., spontaneous tidal volume ), Maximum inspiratory pressure , and rapid shallow breathing index are considered useful parameters for weaning. Although, they have unsatisfactory prediction rates.

Exacerbation of Chronic obstructive pulmonary disease is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management .

In most patients, mechanical ventilation can be discontinued as soon as the underlying reason for acute respiratory failure has been resolved. However, Patients spend receiving mechanical ventilation is devoted to weaning and increase up to, 59% in Chronic obstructive pulmonary disease patients .

There are innumerable factors responsible for the failure of weaning from mechanical ventilation. Factors that should be considered in all patients include misadjusted ventilator settings, infections, airway patency and respiratory muscle performance. Malnutrition, which is common in ventilator dependent patients, has detrimental effects on the respiratory system. Heart failure or coronary ischemia can be induced by the reduction of ventilatory support which causes weaning failure. A number of electrolyte imbalances and psychological problems can be an impediment to successful weaning.

Diaphragmatic ultrasound is non-invasive, radiation-free, widely available, provides immediate and accurate results, and can be repeated at the bedside . Diaphragm sonography values provide useful information for assessing and monitoring mechanically ventilated patients .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patient more than 21 years old of both sexes, coming to our intensive care unit with acute exacerbation of Chronic obstructive pulmonary disease & need mechanical ventilation at least 48 hr.

排除标准

  • •Patient refusal.
  • •Morbid obesity with body mass index > 35 kg/m
  • •Patients with a history of recent thoracic surgery.
  • •Neuromuscular disorders affecting the diaphragm e.g.(myopathy).
  • •Congenital diaphragmatic disorders (Hiatal hernia).

研究组 & 干预措施

conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing

Experimental

Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials

干预措施: conventional clinical criteria and ultrasonic criteria for weaning (Diagnostic Test)

conventional clinical criteria and ultrasonic criteria for weaning

Experimental

Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.

干预措施: conventional clinical criteria of weaning from mechanical ventilation (Diagnostic Test)

结局指标

主要结局

Number of patients with failed weaning trial

时间窗: 28 day

次要结局

  • Time till extubation trial.(28 days)
  • Number of Intensive care unit discharges(28 days)

研究者

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

Shimaa Adel Mohamed Helmy Badr

Resident

Tanta University

研究点 (1)

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