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临床试验/NCT07044063
NCT07044063已完成不适用

Use of Diaphragm Ultrasound and Evaluation of Respiratory Parameters in Determining Weaning Success in Geriatric Patients

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Diaphragm Thickness Measurement

研究概览

简要总结

This study aims to evaluate the effectiveness of ultrasound-based diaphragmatic measurements in predicting weaning success in patients aged 65 and older who are receiving mechanical ventilation. Additionally, it seeks to contribute to the clinical decision-making process by examining the relationship between these measurements and conventional weaning parameters.

详细描述

Weaning refers to the gradual reduction of mechanical ventilatory support. Approximately 40% of the time patients spend on mechanical ventilation is dedicated to the weaning process. Patients who fail the spontaneous breathing trial (SBT) or require reintubation within 48 hours after extubation are considered to have experienced weaning failure. Around 20-30% of patients receiving invasive mechanical ventilation are classified as difficult to wean.

In the geriatric population, the weaning process becomes even more challenging due to age-related changes such as decreased lung elasticity, reduced muscle mass, and diminished lung volumes. Although various scales have been developed to predict weaning success, their correlation with actual clinical outcomes remains uncertain.

The diaphragm is the primary muscle involved in active inspiration. Dysfunction of the diaphragm can lead to impaired cough reflex and respiratory failure. In recent years, ultrasonography (US) has been used to assess diaphragmatic thickness and movement through the right hemithorax during inspiration and expiration. From these measurements, parameters such as Diaphragm Thickness during inspiration and expiration (DTi and DTe), Diaphragm Thickening Fraction (DTF), and Diaphragm Excursion (DE) can be calculated. Several studies have investigated the association between these parameters and weaning success.

In this planned study, the investigators aim to evaluate the predictive value of ultrasound-derived diaphragmatic parameters (DTi, DTe, DTF, and DE) for weaning success in geriatric patients who are intubated and monitored in intensive care units. Additionally, investigators intend to assess the correlation between these parameters and other respiratory indicators.

The primary objective of this study is to examine the relationship between diaphragmatic parameters measured via ultrasonography within 24 hours prior to weaning and weaning outcomes in intubated ICU patients aged 65 years and older. The secondary objective is to compare the correlation of these parameters with other conventional respiratory parameters.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years and older
  • Admitted to ICU
  • Intubated and mechanically ventilated for at least 24 hours
  • Clinically decided to wean from mechanical ventilation

排除标准

  • Those who have mechanically ventilated for more than 14 days
  • Those who have been tracheostomized
  • Those with preexisting diaphragm or lung pathologies
  • Those who had cardiothoracic surgery
  • Those with muscular or musculoskeletal diseases
  • Those with Glasgow Coma Scale lower than 10T without sedation

结局指标

主要结局

Diaphragm Thickness Measurement

时间窗: Within 24 hours prior to weaning from mechanical ventilation.

Diaphragm thicknesses are measured with linear ultrasound probe at 8-10th intercostal space on anterior or middle axillary line using B-mode during inspiration and expiration.

Diaphragmatic Excursion Measurement

时间窗: Within 24 hours prior to weaning from mechanical ventilation.

Diaphragmatic excursion is measured with convex probe at midclavicular line just below costal arch using M-mode during respiratory cycle.

Diaphragm Thickening Fraction

时间窗: Within 24 hours prior to weaning from mechanical ventilation.

Diaphragmatic thickening fraction is calculated by taking the difference between diaphragm thickness at end-inspiration and diaphragm thickness at end-expiration, dividing it by the thickness at end-expiration, and multiplying by 100 to get a percentage.

次要结局

  • Arterial Blood Gas(Within 24 hours prior to weaning from mechanical ventilation.)
  • Oxygen Saturation(Within 24 hours prior to weaning from mechanical ventilation)
  • Respiratory Rate (Breaths per Minute)(Within 24 hours prior to weaning from mechanical ventilation)
  • Rapid Shallow Breathing Index (Breath/Minute/L)(Within 24 hours prior to weaning from mechanical ventilation)
  • Mechanical Ventilation Duration (Hours)(Within 24 hours prior to weaning from mechanical ventilation)
  • PaO2/FiO2 (mmHg)(Within 24 hours prior to weaning from mechanical ventilation.)
  • Tidal Volume and Minute Ventilation (L)(Within 24 hours prior to weaning from mechanical ventilation.)
  • P0.1 (cmH2O)(Within 24 hours prior to weaning from mechanical ventilation.)
  • Dynamic Compliance (mL/cmH2O)(Within 24 hours prior to weaning from mechanical ventilation.)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ismail Yavuz Keles

Resident Doctor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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