Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Respiratory Failure, Extubation Failure, Lung Ultrasonography Score, Diaphragm Thickness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Reintubation Within 72 Hours After Intensive Care Unit Admission [Time frame: From intensive care unit admission to 72 hours after admission]
Secondary outcome measures (3)
- Diaphragm Thickness at Intensive Care Unit Admission [Time frame: Within 0-30 minutes after intensive care unit admission]
- Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission [Time frame: Within 0-30 minutes after intensive care unit admission]
- Lung Ultrasound Score at Intensive Care Unit Admission [Time frame: Within 0-30 minutes after intensive care unit admission]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi — Istanbul
Publications
- Hattori J, Tanaka A, Kosaka J, Hirao O, Furushima N, Maki Y, Kabata D, Uchiyama A, Egi M, Morimatsu H, Mizobuchi S, Kotake Y, Shintani A, Koyama Y, Yoshida T, Fujino Y. Clinical predictors of extubation failure in postoperative critically ill patients: a post-hoc analysis of a multicenter prospective observational study. BMC Anesthesiol. 2025 Mar 15;25(1):127. doi: 10.1186/s12871-025-02996-1. PMID 40089666
- Masaki H, Suzuki S, Nakayama N, Kobayashi E, Fujii A, Nishiwaki K, Mizuno M, Nakatochi M. Risk markers for postoperative reintubation of intensive care unit patients: A retrospective multicentre study of the National Intensive Care Registry. Intensive Crit Care Nurs. 2025 Apr;87:103956. doi: 10.1016/j.iccn.2025.103956. Epub 2025 Feb 3. PMID 39904074
Identifiers
NCT: NCT07672106 · 312923028