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临床试验/NCT07120438
NCT07120438尚未招募不适用

Comparison Between Diaphragmatic Ultrasound and Rapid Shallow Breathing Index (RSBI) in Predicting Weaning Success in Patients on Mechanical Ventilation for More Than 48 Hours in the ICU of Dr. Sardjito Hospital, Yogyakarta

Gadjah Mada University0 个研究点目标入组 55 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
55
主要终点
Extubation Success Rate

研究概览

简要总结

The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours.

The main question it aims to answer is:

Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion [DE] and Diaphragm Thickening Fraction [DTF]) or RSBI, in patients ventilated >48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta?

Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes.

Secondary objectives include:

  1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI.
  2. Evaluating the correlation between DE values and successful weaning.
  3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure.
  4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria.
  5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.

详细描述

This observational cohort study aims to investigate the diagnostic utility of diaphragm ultrasound (specifically diaphragmatic excursion (DE) and diaphragm thickening fraction (DTF)) as alternative weaning predictors in adult ICU patients undergoing mechanical ventilation for more than 48 hours. Given the limitations of the Rapid Shallow Breathing Index (RSBI) in predicting weaning outcomes, ultrasound-based parameters offer a promising physiological assessment tool by directly evaluating diaphragmatic function.

Diaphragm ultrasound will be performed within a defined period prior to planned weaning, following standardized imaging protocols to obtain DE and DTF measurements. All ultrasound assessments will be conducted by trained clinicians using point-of-care ultrasound devices available in the ICU. These values will be compared with the corresponding RSBI obtained as part of routine care, without interfering with the clinical decision-making process.

The study will analyze predictive accuracy metrics (such as sensitivity, specificity, and area under the receiver operating characteristic curve) to compare RSBI with diaphragm ultrasound indices. Subgroup analyses will assess the relationship between suboptimal diaphragm function and weaning failure, as well as evaluate threshold values of DE and DTF that may serve as reliable predictors for extubation outcomes. The study will also explore how these indices correlate with rates of reintubation and prolonged weaning.

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 who have been on mechanical ventilation for more than 48 hours
  • Adult patients aged ≥18 years
  • Patients who meet the criteria for hemodynamic stability for weaning
  • Patients or their families have provided written informed consent
  • Patients with FiO₂ < 50%, PEEP level < 5 cm H₂O, respiratory rate < 30 breaths per minute, PaO₂/FiO₂ > 200, and GCS > 13
  • Patients who have successfully completed the Spontaneous Awakening Trial (SAT) and Spontaneous Breathing Trial (SBT)

排除标准

  • Patients with neuromuscular disorders, anatomical abnormalities of the diaphragm, or diaphragmatic palsy
  • Patients with a history of severe thoracic trauma affecting diaphragm function on one or both sides

结局指标

主要结局

Extubation Success Rate

时间窗: After extubation

Proportion of patients who remain extubated for at least 48 hours following planned extubation.

次要结局

  • Diagnostic Accuracy of RSBI, Diaphragmatic Excursion, and Diaphragmatic Thickening Fraction (DTF) for Predicting Extubation Success(Prior to extubation)

研究者

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meta Restu Synthana

Fellow in Intensive Care

Gadjah Mada University

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