跳至主要内容
临床试验/CTRI/2025/10/096138
CTRI/2025/10/096138尚未招募不适用

Accuracy of cardiorespiratory ultrasound assessment for predicting weaning failure during spontaneous breathing trial: An observational study

Lady Hardinge Medical College1 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26日最近更新:

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
To predict accuracy (of cardiorespiratory ultrasound assessment for weaning failure during spontaneous breathing trial.

研究概览

简要总结

This prospective observational cohort study will be conducted in Lady Hardinge Medical College, New Delhi. Adult patients (more than equal to 18 years) on invasive mechanical ventilation for more than 48 hours who meet standard criteria for a spontaneous breathing trial (SBT) will be enrolled after informed consent. Each participant will undergo comprehensive cardiorespiratory ultrasound assessment—including echocardiographic, lung, and diaphragmatic evaluation—at three stages: during pressure-support ventilation, during SBT on a T-piece, and after SBT completion. Conventional weaning parameters such as the rapid-shallow-breathing index and airway occlusion pressure (P0.1) will also be recorded. Patients will be followed for 48 hours post-extubation to determine weaning success or failure. The diagnostic performance of ultrasound parameters will be analyzed using sensitivity, specificity, predictive values, and area under the ROC curve, with statistical significance set at p < 0.05.

Importance of the Research

Weaning failure remains a major determinant of prolonged ventilation, ICU stay, and mortality in critically ill patients. Conventional indices like the RSBI often fail to identify patients at risk because they assess only ventilatory mechanics and ignore cardiac or diaphragmatic contributions. This study addresses an important gap by evaluating an integrated ultrasound approach that simultaneously examines the heart, lungs, and diaphragm to predict weaning outcomes. If validated, this bedside, non-invasive method could enhance clinical decision-making, reduce extubation-related complications, and improve resource utilization in critical care settings.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group more than equal to 18 years age of either gender who are on invasive mechanical ventilation for more than 48 hours and are eligible for spontaneous breathing trial (SBT).
  • Patients meeting the following criteria for SBT: a.
  • Resolution of the acute phase of the underlying condition that led to mechanical ventilation b.
  • Adequate oxygenation (PaO2/FiO2 more than equal to 200, PEEP less than equal to 8 cm H2O, FiO2 less than equal to 0.4) c.
  • Hemodynamic stability (no vasopressors or low-dose vasopressors) d.
  • Adequate mental status (able to follow commands) e.
  • Temperature less than 38.5°C f.
  • Adequate cough reflex.

排除标准

  • Any pregnant patient
  • Patient having rib fractures or flail chest or severe chest wall deformities
  • Any patient with cervical spine injury
  • Patients having pneumothorax (false lowering of LUS scores-suggesting better aeration than exists)
  • Poor ultrasound image views
  • Documented paradoxical movement of diaphragm or hemi-diaphragm on ultrasound.

结局指标

主要结局

To predict accuracy (of cardiorespiratory ultrasound assessment for weaning failure during spontaneous breathing trial.

时间窗: T1- During SBT on PS 8 cm H20, PEEP less than equal to 5 cm H20- Week 0 (Day of SBT initiation) | T2-During SBT on T-piece Week 0 (same session, following T1) | T3-After SBT- Within 1 hour post-SBT (Week 0)

次要结局

  • 1. Predictive accuracy of individual ultrasound modalities (cardiac, lung, & diaphragm) for weaning failure.(2. Predictive accuracy of conventional weaning parameters (RSBI, P0.1) for weaning failure.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Priyanka Dhar

Lady Hardinge Medical College and associated hospitals

研究点 (1)

Loading locations...

相似试验