Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Şişli, 34360, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07672106
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Istanbul, Şişli, 34360, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: 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.
Time frame: Within 0-30 minutes after intensive care unit admission
Diaphragm thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission. Measurements will be obtained from the same anatomical site with at least three repeated measurements, and the mean value will be used for analysis. Diaphragm thickness values will be evaluated for their association with reintubation within 72 hours.
Time frame: Within 0-30 minutes after intensive care unit admission
Parasternal intercostal muscle thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission. At least three repeated measurements will be obtained, and the mean value will be used for analysis. Parasternal intercostal muscle thickness values will be evaluated for their association with reintubation within 72 hours.
Time frame: Within 0-30 minutes after intensive care unit admission
Lung ultrasound score will be assessed using a 12-region lung ultrasound examination. Each region will be scored from 0 to 3, and the total score will range from 0 to 36. Higher scores indicate greater loss of lung aeration. Lung ultrasound score will be evaluated for its association with reintubation within 72 hours.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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