Combined Predictive Value of RSBI and CALLY Index in Predicting Weaning Success in ICU Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

105 Participants
are grouped into 2 trial groups
Group A: Successful Weaning
Group B: Failed Weaning

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 7 days post-extubation

Secondary outcomes

1

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.

Time frame
28 days post enrollment

Other outcomes

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