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临床试验/CTRI/2024/08/072496
CTRI/2024/08/072496尚未招募不适用

Comparison of airway occlusion pressure with ultrasound based respiratory indices to predict weaning in critically ill patients A prospective observational study

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月15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
70
试验地点
1
主要终点
To compare the area under the receiver operating characteristic curves(AUROCs) of airway occlusion pressure (P0.1), parasternal intercostal muscle thickening fraction/Diaphragm thickening fraction ratio (PMTF/DTF), and Diaphragm thickening fraction/Rapid shallow breathing index ratio (DTF/RSBI) to predict weaning outcome in critically ill mechanically ventilated patients.

研究概览

简要总结

The purpose of this study is to assess the usefulness of various ultrasound based respiratory indices with respiratory drive parameter in better predicting weaning of critically ill patients from mechanical ventilation. Patients are generally intubated and placed on mechanical ventilator when their own ventilatory and/or gas exchange capabilities are outstripped by the demands placed on them from a variety of diseases. As the conditions that warranted placing the patient on the ventilator stabilize and begin to resolve, attention is directed towards discontinuing the mechanical ventilation as quickly as possible. This process is termed “ventilator weaning”. The process allows patients to resume spontaneous breathing after a gradual reduction in ventilatory support and ultimately helps liberate them from mechanical ventilation. Current guidelines suggest several bedside indices to predict successful weaning and extubation. However, none of these indexes have been proven to be optimal in predicting weaning success. Careful clinical assessments are required to determine the patient’s readiness for weaning and subsequent discontinuation of ventilatory support and, ultimately, successful extubation. To facilitate this process in the study, our primary objective will be comparison of area under the receiver operating characteristic curves(AUROCs) of bedside based ultrasound weaning indices measuring parasternal intercostal muscle thickening fraction/diaphragm thickening fraction ratio(PMTF/DTF) and diaphragm thickening fraction/rapid shallow breathing index ratio (DTF/RSBI) and respiratory drive parameter including airway occlusion pressure (P0.1) in critically ill mechanically ventilated patients to predict weaning  outcomes and minimize extubation failure. The secondary objectives would be to compare P0.1, PMTF/DTF ratio and DTF/RSBI ratios on subsequent spontaneous breathing trials, and to correlate PMTF and DTF on the day of discharge from the ICU with the number of days of mechanical ventilation and length of stay . The ultrasound based respiratory indices have a good ability to predict weaning and extubation outcomes. So, by using these indices & parameters together they can serve as a valuable tool for precise clinical prediction of weaning outcomes

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.Adults(age ≥ 18 years) 2.Mechanically ventilated for ≥ 48 hours due to medical or surgical reasons 3.Eligible for a SBT as decided by the intensivist, according to ACCP/ATS/ERS guidelines.

排除标准

  • 1.Neuromuscular disorders affecting respiratory muscles 2.Contraindications for ultrasound examination (e.g., chest wounds, subcutaneous emphysema) 3.Refusal to participate in the study 4.Pregnancy 5.Morbid obesity 6.Neuromuscular blocking agents within 48 hours preceding diaphragm function assessment 7.Pneumothorax, pneumomediastinum, flail chest, or rib fractures 8.Patients primarily ventilated due to cardiac failure 9.Patients with diaphragmatic paralysis/injury on admission.

结局指标

主要结局

To compare the area under the receiver operating characteristic curves(AUROCs) of airway occlusion pressure (P0.1), parasternal intercostal muscle thickening fraction/Diaphragm thickening fraction ratio (PMTF/DTF), and Diaphragm thickening fraction/Rapid shallow breathing index ratio (DTF/RSBI) to predict weaning outcome in critically ill mechanically ventilated patients.

时间窗: 48 hours after Mechanical ventilation

次要结局

  • 1.To compare P0.1, PMTF/DTF ratio, and DTF/RSBI ratios on subsequent spontaneous breathing trials (SBTs)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Lahareesh B L

AIIMS, New Delhi

研究点 (1)

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