Идёт набор NCT07120672

PPI in Weaning Prediction

— Наблюдательное Perfusion Index Weaning of Mechanical Ventilation ICU

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: patients were monitored for reentubation for 48 hours., weaning group.
Кому может быть актуально: Состояния в реестре: Perfusion Index, Weaning of Mechanical Ventilation, ICU. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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%.

The primary outcome is the ability of the Peripheral Perfusion Index (PPI) measured 1 hour after extubation to predict extubation failure within 48 hours.

The secondary outcomes include the predictive ability of PPI measured at the beginning of SBT, at 15 minutes, at the end of SBT, and 2 hours after extubation in identifying patients who will require reintubation within 48 hours.

Вмешательства

Другое patients were monitored for reentubation for 48 hours.
patients were monitored for reentubation for 48 hours.
Другое weaning group
patients were monitored for reentubation for 48 hours.

Первичные конечные точки

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

Вторичные конечные точки (3)

• 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. [Срок оценки: 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. [Срок оценки: 48 hours]
Changes in Peripheric Perfusion Index(PPI) values in patients who experience spontaneous breathing trial(SBT) failure. [Срок оценки: 48 hours]

Критерии участия

Критерии включения

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