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临床试验/NCT07120672
NCT07120672招募中不适用

The Role of Peripheral Perfusion Index as a Predictive Factor During Weaning Process

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月8日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
• The ability of Peripheric Perfusion Index(PPI) measured 1 hour after extubation to predict extubation failure within 48 hours following extubation.

研究概览

简要总结

The aim of this study is to evaluate the predictive role of the Peripheral Perfusion Index (PPI) in forecasting extubation success during the weaning process in intensive care unit (ICU) patients. The study will investigate the ability of PPI to predict extubation failure by comparing it with traditional weaning criteria, including the Rapid Shallow Breathing Index (RSBI), PaO₂/FiO₂ ratio, and respiratory rate.

详细描述

Study Protocol This prospective observational study will be conducted in the Anesthesia Intensive Care Unit of Istanbul Gaziosmanpaşa Training and Research Hospital (SUAM) between March 2025 and June 2025 following approval from the Ethics Committee. Written informed consent will be obtained from the patients' legal representatives prior to enrollment.

Readiness for weaning from mechanical ventilation will be evaluated by the same attending intensivist throughout the study, in accordance with the local protocol. Criteria for readiness include resolution of the underlying cause of mechanical ventilation, ability to tolerate temporary discontinuation of mechanical ventilation, absence of frequent endotracheal suctioning needs, adequate oxygenation (PaO₂ > 60 mmHg with FiO₂ ≤ 0.5 and PEEP ≤ 8 cmH₂O), acceptable pH and PaCO₂ based on the patient's baseline respiratory condition, and stable cardiovascular status. In patients at high risk for upper airway edema, a cuff leak test will be performed by the intensivist.

The spontaneous breathing trial (SBT) will be performed using the Pressure Support (PS) mode with 5 cmH₂O PS and 5 cmH₂O PEEP. After 30 minutes, weaning parameters will be reassessed and the intensivist will make the extubation decision.

SBT failure will be defined by the presence of one or more of the following criteria: altered mental status, respiratory rate > 35 breaths/min, RSBI > 105, signs of increased respiratory effort (use of accessory muscles, thoracoabdominal asynchrony, intercostal retractions), SpO₂ < 90% or PaO₂ < 60 mmHg on FiO₂ of 0.4, or hemodynamic instability (heart rate > 140 bpm, systolic blood pressure > 180 mmHg or < 90 mmHg, or a change in either > 20% from baseline).

Patients with successful SBT will be extubated and monitored for 48 hours for the need for reintubation. Supplemental oxygen will be provided via a simple oxygen mask (4-6 L/min) to maintain SpO₂ > 92%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been on mechanical ventilation for at least 48 hours
  • Patients over 18 years of age who are planned to undergo extubation following a spontaneous breathing trial (SBT)
  • Patients or their legal representatives who provide informed consent to participate in the study

排除标准

  • Patients for whom extubation is not planned due to hemodynamic instability
  • Patients with peripheral vascular disease or a history of hand surgery
  • Patients who die or cannot be followed up during the study period

结局指标

主要结局

• The ability of Peripheric Perfusion Index(PPI) measured 1 hour after extubation to predict extubation failure within 48 hours following extubation.

时间窗: 48 hours

次要结局

  • Changes in Peripheric Perfusion Index(PPI) values in patients who experience spontaneous breathing trial(SBT) failure.(48 hours)
  • • The predictive power of Peripheric Perfusion Index(PPI) measured at the beginning of the spontaneous breathing trial (SBT), at the 15th minute, at the end of SBT, and 2 hours after extubation in determining extubation success.(3 hours)
  • • Correlation of Peripheric Perfusion Index(PPI) measurements between cardiac patients(Patients with at least one diagnosis of cardiac disease) and non-cardiac patients.(48 hours)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

veysel Dinç

Assist. Prof.

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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