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临床试验/NCT06724302
NCT06724302尚未招募不适用

The Accuracy of Ultrasound Assessment of the Thickening Fraction of the Diaphragm, Parasternal Intercostal, and Abdominal Expiratory Muscles for Predicting Weaning Outcomes in Mechanically Ventilated Patients

Tanta University0 个研究点目标入组 80 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
determine the accuracy of the thickening fraction of the diaphragm, parasternal muscles and abdominal expiratory muscles in predicting weaning outcome.

研究概览

简要总结

The accuracy of ultrasound assessment of the thickening fraction of the diaphragm, parasternal intercostal, and abdominal expiratory muscles for predicting weaning outcomes in mechanically ventilated patients. A prospective observational study

详细描述

Mechanical ventilation is a widely used and important life-saving therapeutic approach in the intensive care unit. Nevertheless, it can lead to number of complications, including ventilator-associated lung injury , respiratory muscle dysfunction, and ventilator-associated pneumonia, which can increase healthcare expenses and unfavorable impact on patient outcomes. Prompt cessation of mechanical ventilation is crucial in the management of critically ill patients, however, timing is critical when determining if a patient can be successfully extubated as premature discontinuation of mechanical ventilation can lead to increased cardiovascular and respiratory stress, carbon dioxide (CO2) retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support .

Several parameters have been used to predict weaning outcomes such as minute ventilation, maximum inspiratory pressure, tracheal airway occlusion, dynamic compliance and rapid shallow breathing index (RSBI), but none has shown great prognostic accuracy.

Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. Monitoring of the respiratory muscles function is therefore very useful during the weaning process The diaphragm is the principal respiratory muscle and diaphragmatic dysfunction is a common occurrence in critically ill patients. Therefore, diaphragmatic ultrasonography has been recently proposed as a simple, non-invasive, and bedside method to evaluate diaphragmatic function before any weaning attempt . However, it was highlighted that diaphragm ultrasound is not sufficient for predicting weaning outcomes . When diaphragmatic dysfunction occurs, the extra diaphragmatic respiratory muscles, such as parasternal intercostal muscles (7) and , the expiratory muscles of the abdomen are recruited.(8) Thus, exploring the value of extra diaphragmatic respiratory muscles in predicting weaning outcomes is appropriate . preliminary studies have found that parasternal intercostal and abdominal expiratory muscles' thickness and thickening fraction can be measured by ultrasonography which could provide additional information in the assessment of the respiratory function.

The aim of this study is to evaluate the accuracy of ultrasound assessment of the thickening fraction of the diaphragm, parasternal intercostal, and abdominal expiratory muscles for predicting weaning outcomes in mechanically ventilated patients.

Primary outcome:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be enrolled if they are ≥18 years old, on invasive mechanical ventilation (MV) for more than 48 h and are eligible for first spontaneous breathing trial (SBT) after fulfilling all the following criteria:
  • Resolution or improvement of the disease leading to MV.
  • Adequate oxygenation, indicated by arterial oxygen partial pressure to inspired oxygen fraction (PaO2/FiO2) ≥ 200 mmHg, both with positive end-expiratory pressure (PEEP) ≤ 5 cmH2O and rapid shallow breathing index<
  • Adequate pulmonary function, indicated by a RR<30 breaths/min with VT ≥5 mL/kg ideal body weight (IBW) and no significant respiratory acidosis with normal serum electrolytes.
  • Stable hemodynamics status, without or with minimal vasopressors
  • Conscious and cooperative patient
  • Absence of excessive tracheobronchial secretion (<3 times suction in the past 8 hours).
  • Effective cough reflex .

排除标准

  • Presence of tracheostomy, pleural effusion, pneumothorax, pneumomediastinum, or hemothorax.
  • Presence of rib fractures.
  • Pre-existing cervical spinal injury, history or final diagnosis of neuromuscular disorders, and diaphragmatic paralysis or disorders
  • Use of neuromuscular blocking agents within 48 hours.
  • A distorted abdominal wall anatomy, or damage to the abdominal wall.
  • Patients with localized fluid collections in the abdomen, hernias, abdominal wall hematomas, inguinal masses, femoral hernias, abdominal surgeries.
  • Patients with previously failed SBT

结局指标

主要结局

determine the accuracy of the thickening fraction of the diaphragm, parasternal muscles and abdominal expiratory muscles in predicting weaning outcome.

时间窗: 2 years

Thickness of muscle during inspiration/thickness of muscle during expiration

次要结局

  • 1. Cut-off values of the thickening fraction of the diaphragm, parasternal intercostal, and abdominal expiratory muscles to predict weaning outcomes.(2 years)

研究者

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

Amer Bahir Soliman

Principal investigator

Tanta University

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