- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07656155
Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence
This project plans to employ a multi-center retrospective and prospective cohort study design. It aims to collect data on ventilator support strategies, duration of invasive mechanical ventilation, incidence of ventilator dependence, high-risk factors for ventilator dependence, and in-hospital mortality rates among different chronic disease populations in the ICU. This will involve combining unstructured data with real-time bedside multi-dimensional high-frequency data (including dynamic changes in data volume, respiratory mechanics, diaphragm ultrasound, EIT, diaphragm electrical activity, and other monitoring parameters) to construct digital phenotypes for chronic disease patients with ventilator dependence and identify high-risk factors for ventilator dependence in this population.
Specifically, the research will:
Utilize an integrated modular intelligent respiratory monitoring system, previously developed by the project team, to achieve dynamic monitoring of multi-dimensional indicators.
Systematically collect dynamic clinical characteristics of mechanical ventilation dependence in chronic disease populations through retrospective and prospective cohort studies, and employ multivariate statistical analysis, machine learning, and other techniques to identify no fewer than 5-6 high-risk factors for ventilator dependence in chronic disease patients.
Establish a data ecosystem suitable for chronic disease patients undergoing mechanical ventilation, build a multi-dimensional high-frequency data platform for chronic ventilator-dependent populations, map the full cycle from intubation to mechanical ventilation support, weaning, and extubation, and construct multidimensional digital phenotypes for high-risk chronic disease patients with ventilator dependence.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age > 18 years old.
- Patients admitted to ICU and receiving invasive mechanical ventilation.
- Comorbid with chronic diseases.
Exclusion Criteria:
- Total invasive mechanical ventilation duration ≤ 48 hours.
- Death within 7 days after ICU admission.
- Withdrawal of treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients in the Multicenter Retrospective Cohort
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Patients in the Multi-Center Prospective Cohort
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation
기간: From enrollment to 7 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.
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From enrollment to 7 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
기간: 21 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 14 and 21 days of the initial intubation.
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21 days
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Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Time to first extubation in chronic disease patients
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Proportion of first extubation failure in chronic disease patients
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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High-risk factors for first extubation failure in chronic disease patients
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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ICU mortality rate
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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In-hospital mortality rate
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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ICU length of stay
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Total hospital length of stay
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Duration of invasive mechanical ventilation
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Incidence of Ventilator-Associated Pneumonia (VAP)
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Proportion of patients undergoing tracheostomy
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Time of tracheostomy
기간: during hospitalization,assessed up to 28 days
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among those who receive tracheostomy
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during hospitalization,assessed up to 28 days
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High-risk factors for ventilator dependence in chronic disease patients
기간: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-KY-099
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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