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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07672106
Enrollment
600
Registered
2026-06-26
Start date
2026-04-28
Completion date
2026-10-28
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Thickness, Extubation Failure, Lung Ultrasonography Score, Parasternal Intercostal Muscle Thickness, Postoperative Respiratory Failure

Keywords

lung ultrasonography score, Diaphragm thickness, parasternal intercostal muscle thickness, Postoperative Respiratory Failure

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.

Interventions

None listed

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reintubation Within 72 Hours After Intensive Care Unit AdmissionFrom intensive care unit admission to 72 hours after admissionThe 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.

Secondary

MeasureTime frameDescription
Diaphragm Thickness at Intensive Care Unit AdmissionWithin 0-30 minutes after intensive care unit admissionDiaphragm 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.
Parasternal Intercostal Muscle Thickness at Intensive Care Unit AdmissionWithin 0-30 minutes after intensive care unit admissionParasternal 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.
Lung Ultrasound Score at Intensive Care Unit AdmissionWithin 0-30 minutes after intensive care unit admissionLung 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026