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临床试验/NCT07144878
NCT07144878已完成不适用

Ultrasonographic Assessment of Parasternal Intercostal Muscle Thickness Versus Rapid Shallow Breathing Index for Predicting Weaning From Mechanical Ventilation

Benha University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation

研究概览

简要总结

Mechanical ventilation is essential in the management of critically ill patients, but deciding the proper time to wean and extubate remains a significant challenge. Extubation failure is associated with poor outcomes, including prolonged intensive care unit stay, higher risk of complications, and increased mortality. The rapid shallow breathing index (RSBI) is widely used to predict weaning readiness, but its predictive accuracy is limited. Recently, ultrasound evaluation of respiratory muscles, particularly the parasternal intercostal muscle, has been proposed as a promising bedside tool to assess respiratory effort and load.

This comparative clinical trial was conducted on adult intensive care unit patients at Benha University Hospital who were mechanically ventilated for ≤24 hours and ready for a spontaneous breathing trial. Each patient underwent both rapid shallow breathing index (RSBI) measurement and parasternal intercostal muscle ultrasound prior to the trial. Patients were classified into successful or failed weaning groups based on trial outcome. The study compared the diagnostic accuracy of both methods and aimed to determine whether ultrasound assessment of the parasternal intercostal muscle offers a more reliable predictor of weaning success than rapid shallow breathing index (RSBI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

No masking was applied. Both investigators and treating clinicians were aware of the diagnostic tests performed.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 years or older
  • •Both sexes
  • •Patients invasively mechanically ventilated for up to 24 hours and ready to undergo a spontaneous breathing trial
  • •Patients considered ready for spontaneous breathing trial if all of the following were met:
  • •Alert and afebrile
  • •Fraction of inspired oxygen less than 50 percent
  • •Positive end-expiratory pressure less than or equal to 8 centimeters of water
  • •Ratio of arterial oxygen partial pressure to fraction of inspired oxygen greater than 200
  • •Arterial blood pH between 7.35 and 7.45
  • •Respiratory rate less than or equal to 35 breaths per minute
  • •Hemodynamically stable without vasopressor support

排除标准

  • •Age younger than 18 years
  • •Pregnancy
  • •Surgical dressings near or over the sternum that prevent ultrasound examination
  • •Body mass index less than 18.5 kilograms per square meter (underweight)
  • •Body mass index greater than or equal to 40 kilograms per square meter (morbid obesity)
  • •Primary neuromuscular diseases

研究组 & 干预措施

Parasternal Intercostal Ultrasound and RSBI Assessment

Other

All enrolled patients underwent ultrasonographic assessment of the parasternal intercostal muscle thickness and calculation of thickening fraction, as well as measurement of the Rapid Shallow Breathing Index (RSBI) using standard ventilator settings. These assessments were performed prior to a 30-minute spontaneous breathing trial. Patients were subsequently classified into successful or failed weaning groups based on trial outcome.

干预措施: Parasternal Intercostal Ultrasound and RSBI Assessment (Diagnostic Test)

结局指标

主要结局

Diagnostic accuracy of parasternal intercostal muscle thickening fraction measured by ultrasound versus Rapid Shallow Breathing Index for predicting successful weaning from mechanical ventilation

时间窗: Baseline, immediately prior to the spontaneous breathing trial

The outcome was assessed by comparing two diagnostic measurements: (1) parasternal intercostal muscle thickening fraction, calculated as the difference between end-inspiratory and end-expiratory muscle thickness divided by end-expiratory thickness, measured using bedside ultrasound; and (2) the Rapid Shallow Breathing Index, calculated as respiratory rate divided by tidal volume, recorded from ventilator-displayed values under standardized zero-support settings. Predictive accuracy for successful weaning was evaluated using receiver operating characteristic analysis, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve. Successful weaning was defined as tolerating a 30-minute spontaneous breathing trial without signs of failure.

次要结局

  • Sensitivity and specificity of parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index in predicting successful weaning(Baseline, immediately prior to the spontaneous breathing trial)
  • Comparison of area under the receiver operating characteristic curve between parasternal intercostal muscle thickening fraction and Rapid Shallow Breathing Index(Baseline, immediately prior to the spontaneous breathing trial)

研究者

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

Reham Mahmoud Ahmed Shady

Assistant Lecturer of Critical Care Medicine

Benha University

研究点 (1)

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