- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07571317
Combined Predictive Value of RSBI and CALLY Index in Predicting Weaning Success in ICU Patients
Combined Predictive Value of Rapid Shallow Breathing Index (RSBI) and CRP-Albumin-Lymphocyte (CALLY) Indices in Predicting the Success of Weaning From Mechanical Ventilation in Intensive Care Patients: A Prospective Observational Study
Panoramica dello studio
Stato
Descrizione dettagliata
This prospective observational study aims to evaluate the combined predictive value of the Rapid Shallow Breathing Index (RSBI) and CRP-Albumin-Lymphocyte (CALLY) index in determining the success of weaning from mechanical ventilation in intensive care patients. While the RSBI focuses on physiological respiratory mechanics, the CALLY index serves as a non invasive biomarker reflecting the patient's immunonutritional and inflammatory status.
Data collection is deepened through systematic retrieval from the Hospital Information Management System. Researchers will record a wide range of parameters, including demographic data such as age, gender, and BMI alongside clinical severity scores including APACHE II, SOFA, and the Charlson Comorbidity Index. Real time respiratory profiling, including minute ventilation, tidal volume, and airway pressures, will be documented during the weaning process and the Spontaneous Breathing Trial (SBT).
Laboratory integration focuses on routine markers such as CRP, albumin, and lymphocyte counts to determine the patient's biological status at the time of the SBT. In this study, the CALLY Index is generalized as a ratio of the patient's immuno-nutritional reserve to systemic inflammation, calculated as: (Albumin x Lymphocyte Count) / CRP.
The primary outcome is defined as weaning success, characterized by the patient remaining free from invasive mechanical ventilation following extubation. To ensure a comprehensive evaluation of respiratory stability, this study extends the primary observation period to include both the initial 48 hour window and a 7 day follow-up. By incorporating the 7 day parameter, the researchers aim to capture both immediate and late-phase weaning failures, providing a more robust assessment of the combined indices' predictive power for long term extubation success. Secondary outcomes include 28 day mortality rates and total duration of intensive care stay.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: mahmut baran kasisari, medical doctor
- Numero di telefono: +905072225254
- Email: barankasisari@hotmail.com
Backup dei contatti dello studio
- Nome: tugba yesilyurt dogu, medical doctor
- Numero di telefono: +905535150847
- Email: tugbaayesilyurt@gmail.com
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye), 34480
- Reclutamento
- Başakşehir Çam and Sakura City Hospital
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Contatto:
- mahmut baran kasisari, Medical Doctor
- Numero di telefono: 905072225254
- Email: barankasisari@hotmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Successful Weaning
Patients who maintain respiratory stability without reintubation, rescue ventilation, or death during both the initial 48 hours post-extubation and the 7-day follow-up period.
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Failed Weaning
Patients who experience reintubation, need for rescue ventilation, or mortality either within the first 48 hours post-extubation or during the 7-day monitoring phase.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite Weaning Success and Respiratory Stability Rate
Lasso di tempo: Up to 7 days post-extubation
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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.
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Up to 7 days post-extubation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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28-Day Mortality Rate
Lasso di tempo: 28 days post enrollment
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This measure calculates the total number of days a patient requires invasive mechanical ventilation support during their stay in the intensive care unit.
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28 days post enrollment
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E-96317027-514.10-311839049
- KAEK-11/15.04.2026.138 (Altro identificatore: Ethics Committee Approval Number)
Piano per i dati dei singoli partecipanti (IPD)
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