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临床试验/NCT07634783
NCT07634783尚未招募不适用

Prospective Observational Single-Center Physiological Study Evaluating Dynamic Stress Estimated by Delta Pocc During a Pressure Support Spontaneous Breathing Trial (PSV 8 cmH2O, PEEP 0 cmH2O) as a Predictor of Extubation Failure in Mechanically Ventilated Adult ICU Patients

Sanatorio Parque, Argentina1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1

研究概览

简要总结

This prospective observational single-center study will evaluate whether dynamic respiratory stress estimated by delta airway occlusion pressure deflection (Delta Pocc) during a standardized spontaneous breathing trial can predict extubation failure in mechanically ventilated adult intensive care unit patients.

Liberation from invasive mechanical ventilation is a critical step in ICU care. Although spontaneous breathing trials are routinely used to assess readiness for extubation, some patients may successfully complete the trial despite experiencing excessive respiratory effort and physiological stress, which may increase the risk of extubation failure.

This study will include adult ICU patients who have received invasive mechanical ventilation for at least 24 hours and are considered ready for a spontaneous breathing trial according to the treating clinical team. During the trial, respiratory, ventilatory, and hemodynamic variables will be recorded at predefined time points, including measurements of Delta Pocc as a non-invasive estimate of inspiratory effort and dynamic stress.

The primary outcome is extubation failure within 48 hours after extubation, defined as reintubation and/or the need for rescue non-invasive respiratory support due to post-extubation respiratory deterioration.

The study aims to determine whether this physiological measurement may improve risk stratification during weaning and complement conventional clinical decision-making.

详细描述

Background

Liberation from invasive mechanical ventilation requires integration of clinical, hemodynamic, gas exchange, and physiological criteria. The spontaneous breathing trial (SBT) is a standard component of the weaning process and is commonly used to assess readiness for extubation. However, conventional clinical parameters may not fully capture the true respiratory workload experienced by the patient during the trial.

Some patients may tolerate a spontaneous breathing trial according to standard criteria while still developing excessive inspiratory effort and elevated dynamic respiratory stress, potentially predisposing them to post-extubation respiratory failure. Identifying these patients before extubation remains a major clinical challenge.

Delta airway occlusion pressure deflection (Delta Pocc), obtained during a brief expiratory occlusion maneuver, has emerged as a non-invasive physiological surrogate for inspiratory effort and dynamic transpulmonary stress. Incorporating this measurement into routine spontaneous breathing trial assessment may improve identification of patients at increased risk of extubation failure.

Objective

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

  • Age 18 years or older
  • Invasive mechanical ventilation for at least 24 hours
  • Clinical indication for spontaneous breathing trial according to the treating clinical team
  • Hemodynamic and clinical stability
  • Technical feasibility for respiratory physiological measurements, including expiratory occlusion maneuver

排除标准

  • Significant hemodynamic instability
  • Severe uncontrolled hypoxemia
  • Major cardiac arrhythmias
  • Agitation or patient-ventilator asynchrony preventing reliable measurements
  • Significant air leak interfering with respiratory measurements
  • Technical inability to perform expiratory occlusion maneuver
  • Limitation of life-sustaining treatment
  • Incomplete primary outcome follow-up

研究组 & 干预措施

Mechanically Ventilated Adult ICU Patients Undergoing Spontaneous Breathing Trial

干预措施: Delta Pocc Measurement During Spontaneous Breathing Trial (Diagnostic Test)

研究者

发起方
Sanatorio Parque, Argentina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musso Gabriel Andres

Principal Investigator, Adult Intensive Care Unit

Sanatorio Parque, Argentina

研究点 (1)

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