About this trial
The primary objective of this prospective observational study is to evaluate the effectiveness of combining the Rapid Shallow Breathing Index (RSBI) and CRP-Albumin-Lymphocyte (CALLY) index to predict weaning success in adult patients within the intensive care unit. While weaning from mechanical ventilation is a critical clinical step, existing physiological metrics like RSBI do not fully capture a patient's inflammatory or nutritional status. This research introduces the CALLY index calculated as the ratio of the patient's immuno-nutritional reserve (Albumin and Lymphocytes) to systemic inflammation (CRP) as a complementary metabolic marker. By tracking approximately 105 participants at Basaksehir Cam and Sakura City Hospital, the study monitors weaning success over both a 48 hour and a 7 day period to identify both immediate and late phase extubation failures. The ultimate goal is to provide a more holistic prediction model that potentially reduces re-intubation rates and improves clinical outcomes by accurately identifying the optimal time for ventilator removal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older
Patients who have received invasive mechanical ventilation for at least 24 hours in the general intensive care unit.
Disqualifiers
Patients under the age of 18.
Patients with a known or detected pregnancy.
Patients with a diagnosis of malignancy.
Patients with neuromuscular diseases that could impair respiratory effort or muscle strength assessments (e.g., Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Guillain-Barré syndrome).
Trial population
The study population consists of adult patients hospitalized in the General Intensive Care Units of Basaksehir Cam and Sakura City Hospital who have been receiving invasive mechanical ventilation for at least 24 hours. Participants are identified from patients who meet the clinical requirements for a Spontaneous Breathing Trial and are considered candidates for weaning by the attending intensivist. The population represents a diverse group of critically ill patients requiring prolonged respiratory support, excluding those with specific confounding factors such as pregnancy, malignancy, or primary neuromuscular disorders
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Composite Weaning Success and Respiratory Stability Rate
The proportion of patients who remain free from invasive mechanical ventilation following extubation. Success is defined as the absence of reintubation, need for rescue ventilation, or death within two stages: 1) Immediate weaning success within the first 48 hours postextubation, and 2) Sustained respiratory stability throughout a 7 day follow-up period to capture late-phase weaning failures.
Secondary outcomes
28-Day Mortality Rate
This measure calculates the total number of days a patient requires invasive mechanical ventilation support during their stay in the intensive care unit.
Sponsors and contacts
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