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- Ensayo clínico 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
Descripción general del estudio
Estado
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: mahmut baran kasisari, medical doctor
- Número de teléfono: +905072225254
- Correo electrónico: barankasisari@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: tugba yesilyurt dogu, medical doctor
- Número de teléfono: +905535150847
- Correo electrónico: tugbaayesilyurt@gmail.com
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34480
- Reclutamiento
- Başakşehir Çam and Sakura City Hospital
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Contacto:
- mahmut baran kasisari, Medical Doctor
- Número de teléfono: 905072225254
- Correo electrónico: barankasisari@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite Weaning Success and Respiratory Stability Rate
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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28-Day Mortality Rate
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E-96317027-514.10-311839049
- KAEK-11/15.04.2026.138 (Otro identificador: Ethics Committee Approval Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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