Evaluation of Mechanical Power to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mechanical Power (MP)
研究概览
简要总结
The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are:
Can the mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes?
Participants will:
- Be adult ICU patients planned for weaning from mechanical ventilation.
- Undergo bedside ventilatory assessment within 2 hours after meeting clinical weaning criteria.
- Have the following respiratory parameters measured: MP, P0.1, NIF, and RSBI.
- Be monitored for 48 hours after extubation to assess weaning success (defined as no need for reintubation after extubation)
详细描述
This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.
Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.
All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.
Data collection will include:
Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.
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
- 否
入选标准
- •Age ≥ 18 years (adult patient population)
- •Patients receiving invasive mechanical ventilation in the intensive care unit
- •Having been intubated for at least 24 hours
- •Patients for whom the clinical team has decided extubation and who meet the following weaning criteria:
- •Stable respiratory parameters (FiO₂ ≤ 50%, PEEP ≤ 7 cmH₂O, SpO₂ ≥ 92%)
- •Hemodynamic stability (no inotropic support or minimal/stable dose)
- •Stable acid-base balance
- •Adequate secretion control
- •Technically suitable ventilator and measurement conditions
- •Written informed consent obtained from the patient or legal representative
排除标准
- •Patients with any of the following conditions will be excluded:
- •Individuals under 18 years of age
- •Pregnant patients
- •Patients who do not meet the weaning criteria
- •Tracheostomized patients
- •Neuromuscular diseases (e.g., Guillain-Barré syndrome, Duchenne muscular dystrophy, etc.)
- •Technical inadequacy preventing correct ventilator measurements
- •Significant asynchrony (e.g., auto-PEEP, double triggering, ineffective triggering, cycle asynchrony, auto-triggering)
- •Patients without an extubation plan or those receiving palliative care
- •RASS ≤ -2 (excessive sedation) for PSV mode measurements
- •RASS ≥ +2 (agitation) for PSV-CPAP mode measurements
- •Patients with delirium for PSV-CPAP mode measurements
- •Patients who cannot provide consent, have no legal representative, or whose representative refuses consent
结局指标
主要结局
Mechanical Power (MP)
时间窗: 48 hour
Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
次要结局
- Airway Occlusion Pressure at 100 ms (P0.1)(48 hour)
- Negative Inspiratory Force (NIF)(48 hour)
- Rapid Shallow Breathing Index (RSBI)(48 hour)
- Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio)(48 hour)
研究者
Anıl Berkay Balıtatlı
Resident Physician (Anesthesiology and Intensive Care)
Kanuni Sultan Suleyman Training and Research Hospital