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临床试验/CTRI/2025/03/081652
CTRI/2025/03/081652尚未招募不适用

Prediction of extubation outcome using Occlusion airway pressure (P 0.1) value over Rapid shallow breathing index (RSBI) in the intensive care unit

Prajna N S1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2025年3月11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
77
试验地点
1
主要终点
To evaluate the predictive accuracy of P 0.1 values over RSBI scores during

研究概览

简要总结

This prospective observational study aims to compare the predictive accuracy of P0.1 over RSBI in determining successful weaning outcomes in mechanically ventilated ICU patients. 77 patients will be selected based on the inclusion and exclusion criteria using the consecutive sampling method. Eligible patients will undergo a spontaneous breathing trial (SBT), during which P0.1 and RSBI values will be recorded at 30, 45, and 60 minutes. The study aims to evaluate the predictive accuracy of Occlusion Airway Pressure (P0.1) compared to the Rapid Shallow Breathing Index (RSBI) in determining successful weaning outcomes and assessing reintubation incidence among extubated patients. The  outcome of the study is to evaluate the predictive accuracy of P0.1 values over RSBI scores during weaning trials in determining extubation failure rates. Continuous variables (e.g., age, APACHE II, and SOFA scores) will be expressed as mean ± standard deviation (SD) and categorical variables as counts and percentages. The predictive accuracy of P0.1 and RSBI will be assessed using Receiver Operating Characteristic (ROC) curve analysis, comparing the area under the curve (AUC) values to determine the superior predictor.

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

  • Age: 18 years and older.
  • Any gender.
  • Intubated patient on mechanical ventilator more than 24 hours.
  • Mechanically ventilated patients who are considered for weaning trials.
  • Planned extubation.

排除标准

  • Age less than 18 years.
  • Neurological Conditions: Conditions affecting respiratory drive or consciousness (e.g., severe brain injury).
  • Discharge against medical advice patients
  • Self extubated patients
  • Tracheostomised patients.
  • Extubation for palliative care.

结局指标

主要结局

To evaluate the predictive accuracy of P 0.1 values over RSBI scores during

时间窗: After 30min,45min, 1hour of SBT Trail

weaning trials in determining extubation failure rates.

时间窗: After 30min,45min, 1hour of SBT Trail

次要结局

未报告次要终点

研究者

发起方
Prajna N S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prajna N S

KMC Mangalore

研究点 (1)

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