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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult postoperative patients aged 18 years and older who are admitted to the anesthesia and reanimation intensive care units after major surgery, including abdominal, vascular, orthopedic, and ear, nose, throat, head and neck surgery. Eligible patients will be those extubated in the operating room and admitted to the intensive care unit with spontaneous breathing during the study period after ethics committee approval.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 2 trial groups
Group A: Reintubation group
Group B: No reintubation group

Trial outcomes

Primary outcomes

1

Reintubation Within 72 Hours After Intensive Care Unit 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
From intensive care unit admission to 72 hours after admission

Secondary outcomes

1

Diaphragm Thickness at 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
2

Parasternal Intercostal Muscle Thickness at 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
3

Lung Ultrasound Score at 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.

Time frame
Within 0-30 minutes after intensive care unit admission

Other outcomes

Sponsors and contacts

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