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临床试验/CTRI/2025/11/096900
CTRI/2025/11/096900尚未招募不适用

Predictive Value of HACOR Score Plus Lung Ultrasound Score [HACOR-LUS] for Prediction of Non-Invasive Ventilation (NIV) Failure in Acute Exacerbation of COPD (AECOPD) Patients: A Single-Centre Prospective Study

All India Institute of Medical Sciences Kalyani1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年11月20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
140
试验地点
1
主要终点
To evaluate the predictive value of the combined HACOR score and Lung Ultrasound Score (LUS) that is HACOR-LUS value for NIV failure in patients with AECOPD. HACOR and LUS will be assessed at baseline (within 2 hours of NIV initiation)

研究概览

简要总结

This observational study is designed to assess whether the combination of the HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) and the Lung Ultrasound Score (LUS) can enhance the prediction of non-invasive ventilation (NIV) failure in patients hospitalised due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD). NIV is a recognised treatment for respiratory failure related to AECOPD; however, about a third of patients experience NIV failure, which is linked to poor outcomes. Early detection of individuals likely to experience NIV failure is essential for prompt escalation to invasive ventilation and improved prognosis. Around 140 adult patients with AECOPD requiring NIV will be recruited over a six-month period at the Department of Trauma and Emergency Medicine, AIIMS Kalyani. HACOR and LUS will be evaluated within 2 hours of starting NIV. The predictive capabilities of each score individually and their combined effect (HACOR-LUS), for NIV failure will be analyzed using ROC curve analysis and logistic regression. The study aims to develop a straightforward, bedside composite model to assist clinicians in the early risk stratification and management of AECOPD patients undergoing NIV.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Hospitalized with a diagnosis of AECOPD requiring NIV
  • Informed consent obtained.

排除标准

  • Immediate need for intubation at presentation
  • Contraindications to NIV
  • Other causes of respiratory failure (e.g., pneumonia without COPD, pulmonary edema, neuromuscular disease)
  • Refusal of consent.

结局指标

主要结局

To evaluate the predictive value of the combined HACOR score and Lung Ultrasound Score (LUS) that is HACOR-LUS value for NIV failure in patients with AECOPD. HACOR and LUS will be assessed at baseline (within 2 hours of NIV initiation)

时间窗: at baseline (within 2 hours of NIV initiation)

次要结局

  • 1.To identify clinical & demographic factors associated with NIV failure.(2. To assess the ventilator days & weaning outcome in High HACOR-LUS score patients)

研究者

发起方
All India Institute of Medical Sciences Kalyani
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Biswajit Naskar

All India Institute of Medical Sciences Kalyani

研究点 (1)

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