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

NCT07571317 | Not Yet Recruiting

• 2 other identifiers: E-96317027-514.10-311839049KAEK-11/15.04.2026.138
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective observational study is to evaluate the effectiveness of combining the Rapid Shallow Breathing Index (RSBI) and the 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.

Conditions

Mechanical Ventilation Weaning Failure; Critical Illness; Respiratory Insufficiency; Ventilator Weaning

Keywords

mechanical ventilation; ventilator weaning; Systemic Inflammation; CRP-Albumin-Lymphocyte Ratio

Outcome Measures

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.

  Up to 7 days post-extubation

Secondary Outcomes (1)

• 28-Day Mortality Rate

  28 days post enrollment

Study Arms (2)

Successful Weaning

Failed Weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Patients aged 18 years and older
• Patients who have received invasive mechanical ventilation for at least 24 hours in the general intensive care unit.
• Patients who meet standard clinical weaning criteria (e.g., hemodynamic stability with minimal or no vasopressor support, adequate cough reflex, absence of excessive airway secretions).
• Patients deemed ready for a Spontaneous Breathing Trial by the attending physician.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

mahmut baran kasisari, medical doctor

CONTACT

+905072225254; barankasisari@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)