See if reintubation risk can be predicted after major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this prospective observational study, adult postoperative ICU patients who were extubated in the OR and are breathing spontaneously will undergo bedside ultrasound assessments of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score within the first hours after ICU admission. The ROX index will be calculated from oxygen saturation, inspired oxygen, and respiratory rate, and perioperative fluid balance will be recorded. Patients will be followed for 48 to 72 hours to see if reintubation is required. This study aims to identify early markers that could indicate reintubation risk in a real-world ICU setting without intervening treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
  Istanbul, Şişli, Turkey (Türkiye) Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

• Early warning and stratified diagnosis of postoperative respiratory failure using ventilator waveform features

  This study tests whether patterns in ventilator waveforms can predict and categorize risk of breathing failure after surgery for adults on mechanical ventilation.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07799636

• Lowering driving pressure during surgeries with high risk of postoperative lung complications

  This trial tests whether using the lowest possible driving pressure during mechanical ventilation instead of standard protective settings helps adults having high-risk surgery avoid postoperative lung complications.

  Recruiting University General Hospital of Patras · Pátrai · NCT07186933

• Readiness for EXtubation (REXs) score for patients on invasive mechanical ventilation

  This will test the Readiness for EXtubation (REXs) score to see if it can predict which ICU patients on invasive mechanical ventilation can be safely extubated.

  Recruiting at 7 sites Medipol University · Punta Arenas and 6 other locations · NCT07098611

• ICU rehabilitation for adults on invasive mechanical ventilation

  This project will look at rehabilitation approaches used in ICUs worldwide to see if they relate to outcomes for adults who have been on invasive mechanical ventilation for at least 48 hours.

  Recruiting Universita degli Studi di Genova · Genova, Italy · NCT07093125

• Using noninvasive breathing support for severely obese patients after extubation

  This study is testing if using a combination of noninvasive breathing support methods can help severely obese patients breathe better after being taken off a ventilator and reduce the chances of needing to be put back on one.

  Recruiting at 4 sites Rush University Medical Center · Chicago, Illinois and 4 other locations · NCT05918575

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.