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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:mahmut baran kasisari, medical doctor
- 電話番号:+905072225254
- メール:barankasisari@hotmail.com
研究連絡先のバックアップ
- 名前:tugba yesilyurt dogu, medical doctor
- 電話番号:+905535150847
- メール:tugbaayesilyurt@gmail.com
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ(Türkiye)、34480
- 募集
- Başakşehir Çam and Sakura City Hospital
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コンタクト:
- mahmut baran kasisari, Medical Doctor
- 電話番号:905072225254
- メール:barankasisari@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite Weaning Success and Respiratory Stability Rate
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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28-Day Mortality Rate
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- E-96317027-514.10-311839049
- KAEK-11/15.04.2026.138 (その他の識別子:Ethics Committee Approval Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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