NCT07672106 Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 600 participants in total. It began in 2026-04-28 with a primary completion date of 2026-10-28.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

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