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临床试验/CTRI/2024/01/061846
CTRI/2024/01/061846尚未招募不适用

Sonographic Assessment of Diaphragmatic Indices for Predicting Weaning in Patients on Mechanical Ventilation

Vardhman Mahavir Medical College and Sadarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2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
60
试验地点
1
主要终点
1.To assess the accuracy of diaphragmatic indices (Diaphragm excursion, Time to peak amplification, and diaphragm thickness fraction) by ultrasonography to predict successful weaning in patients on mechanical ventilation.

研究概览

简要总结

A great number of critically ill patients in intensive care unit require invasive mechanical ventilation as a part of their care. Despite being life savior, liberation from ventilator is very challenging and time consuming. Untimely discontinuation of mechanical ventilation may lead to amplified cardiovascular and respiratory stress, CO2 retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in weaning from mechanical ventilation can also be deleterious. Complications such as ventilator associated pneumonia and ventilator induced diaphragm atrophy can be seen even with short periods of mechanical ventilation thereby prolonging mechanical ventilation.

Nevertheless, mechanical ventilation or the underlying ailment can lead to diaphragmatic dysfunction, a condition that may contribute to weaning failure. Extended      time on the ventilator greatly increases patient morbidity and mortality. Symptoms and signs of muscle disease in ICU patient are often difficult to evaluate because of concomitant confounding factors. Weaning is a continuous process, which starts with recognition of patient being ready to be weaned off from ventilator. Several parameters such as rapid shallow breathing index, vital capacity and maximum peak inspiratory pressure are being used routinely to extubate a patient from mechanical ventilator but the sensitivity, specificity, positive predictive value, and negative predictive values are highly variable. Moreover, these parameters do not assess the diaphragm dysfunction which is the major respiratory muscle and prime cause for the weaning failure.

Conservative assessment of diaphragm function lacks  specific, noninvasive, time-saving, and easily performed bedside tools or requires patient cooperation. In recent times, the use of ultrasound has risen as a simple, noninvasive method of quantification of diaphragmatic excursion and contractile activity. Ultrasonography is a feasible, relatively inexpensive, radiation-free imaging modality which allows the visualization of muscle contractions; and has been shown to used successfully at bedside to evaluate diaphragm dysfunction, which is taken to be diaphragmatic excursion < 10mm and diaphragmatic thickness fraction <30%. It can distinguish between diaphragmatic paralysis, paradoxical upward movement, or immobility of the diaphragm.

Hence, we aim to assess the diaphragmatic indices by ultrasound for predicting weaning outcome in patients on mechanical ventilation in the ICU setting.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1-Age > 18 years 2-On mechanical ventilator ≥48 hours.

排除标准

  • 1-History of neuromuscular disease, diaphragmatic palsy, thoracic surgery, any mass or mechanical factor in chest or abdomen 2-Low Glasgow coma score 3-Pregnancy, ascites, morbid obesity 4-Increased intra-abdominal pressure.
  • 5-Lung collapse and large pleural effusion.

结局指标

主要结局

1.To assess the accuracy of diaphragmatic indices (Diaphragm excursion, Time to peak amplification, and diaphragm thickness fraction) by ultrasonography to predict successful weaning in patients on mechanical ventilation.

时间窗: At the time, just before extubation of the patient from mechanical ventilator.

2.To evaluate the best measured variables to predict successful weaning .

时间窗: At the time, just before extubation of the patient from mechanical ventilator.

次要结局

  • 1.To compare diaphragmatic parameters with Rapid shallow breathing index (RSBI).(2.To assess the association between diaphragmatic indices & diaphragmatic dysfunction & reintubation)

研究者

发起方
Vardhman Mahavir Medical College and Sadarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kirankumar C

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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