- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: mahmut baran kasisari, medical doctor
- 전화번호: +905072225254
- 이메일: barankasisari@hotmail.com
연구 연락처 백업
- 이름: tugba yesilyurt dogu, medical doctor
- 전화번호: +905535150847
- 이메일: tugbaayesilyurt@gmail.com
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34480
- 모병
- Başakşehir Çam and Sakura City Hospital
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연락하다:
- mahmut baran kasisari, Medical Doctor
- 전화번호: 905072225254
- 이메일: barankasisari@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite Weaning Success and Respiratory Stability Rate
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-Day Mortality Rate
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- E-96317027-514.10-311839049
- KAEK-11/15.04.2026.138 (기타 식별자: Ethics Committee Approval Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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