Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Reintubation Within 72 Hours After Intensive Care Unit Admission
研究概览
简要总结
This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Reintubation after extubation is an important clinical problem because it may increase complications, prolong mechanical ventilation, and extend intensive care and hospital stay.
The study will include adult patients who are extubated in the operating room and admitted to the intensive care unit with spontaneous breathing. Within the first hours after ICU admission, bedside ultrasound measurements of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score will be performed. The ROX index will also be calculated using oxygen saturation, inspired oxygen concentration, and respiratory rate. Perioperative fluid balance will be recorded from anesthesia and patient files.
Patients will be followed for 48 to 72 hours after ICU admission to determine whether reintubation is required. The study aims to assess whether respiratory muscle ultrasound findings, lung ultrasound score, ROX index, and perioperative fluid balance can help predict reintubation risk in postoperative ICU patients. No additional treatment or intervention will be applied as part of the study, and all clinical decisions will be made by the responsible intensive care team according to routine clinical practice.
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
- •Adult patients aged 18 years and older
- •Patients requiring postoperative intensive care follow-up after major surgery, including abdominal, vascular, orthopedic, or ear, nose, throat, head and neck surgery
- •Patients extubated in the operating room and admitted to the intensive care unit with spontaneous breathing
- •Patients without any clinical condition preventing the planned measurements within the first 0-2 hours after ICU admission (T0 and T1)
- •Patients for whom written informed consent can be obtained from the patient or legally authorized representative
- •Patients admitted to the intensive care unit within the specified study period after ethics committee approval and enrolled consecutively
排除标准
- •Patients younger than 18 years of age
- •Patients who leave the operating room intubated or are admitted to the intensive care unit while intubated
- •Patients with a tracheostomy
- •Patients with a history of diaphragmatic paralysis
- •Patients with a significant neuromuscular disease, such as ALS, myasthenia gravis, or similar conditions
- •Patients with conditions that significantly prevent ultrasound measurements, including marked subcutaneous emphysema, large dressings or bandages covering the measurement area, inability to access the measurement site due to drains or the surgical field, or inability to obtain technically adequate images
- •Patients in whom the planned measurements cannot be performed due to clinical instability requiring emergency intubation immediately after ICU admission
- •Patients from whom informed consent cannot be obtained, or patients or legally authorized representatives who refuse participation
研究组 & 干预措施
Reintubation group
Reintubation group
No reintubation group
No reintubation group
结局指标
主要结局
Reintubation Within 72 Hours After Intensive Care Unit Admission
时间窗: From intensive care unit admission to 72 hours after admission
The primary outcome is the development of reintubation within the first 72 hours after admission to the intensive care unit. Reintubation is defined as the need for endotracheal intubation after initial extubation in the operating room and admission to the intensive care unit with spontaneous breathing. The decision for reintubation will be made by the responsible intensive care team according to routine clinical criteria and independently of the study protocol. The outcome will be recorded as yes or no.
次要结局
- Diaphragm Thickness at Intensive Care Unit Admission(Within 0-30 minutes after intensive care unit admission)
- Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission(Within 0-30 minutes after intensive care unit admission)
- Lung Ultrasound Score at Intensive Care Unit Admission(Within 0-30 minutes after intensive care unit admission)
研究者
Reyhan Kucuk Erturk
Principal Investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization