Predictive Model for High-Flow Nasal Cannula Failure Based on Metabolomics and Clinical Data: COVID-19 As a Use Case
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Predictive Model Development
研究概览
简要总结
The aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. By combining clinical data and metabolomic profiles, the study seeks to answer:
- Can integrating clinical parameters with metabolomic markers enhance the prediction of HFNC failure in AHRF patients?
Participants with AHRF due to SARS-CoV-2 receiving HFNC under standard-of-care protocols will be monitored until hospital discharge or death. Blood samples for metabolomic analysis will be collected at inclusion.
详细描述
This prospective observational cohort study focuses on developing and validating a predictive model for HFNC failure in patients with SARS-CoV-2-related AHRF, combining clinical parameters and metabolomic profiling. Patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (T0) for laboratory and metabolomic analyses.
The study consists of two cohorts: a Training Cohort (March 2020 to April 2021) for model development and a Validation Cohort (May 2021 to October 2021) for model validation and external testing. HFNC outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (OTI). Advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data.
This model seeks to enhance early identification of HFNC failure risk, enabling timely interventions and personalized management in critically ill AHRF patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old) with acute hypoxemic respiratory failure (AHRF) confirmed as secondary to SARS-CoV-2 infection via PCR testing.
- •Requirement for high-flow nasal cannula (HFNC) initiated within 48 hours of hospital admission.
排除标准
- •Patients under the age of 18
- •Patients with active "do not resuscitate" (DNR) orders at the time of inclusion.
结局指标
主要结局
Predictive Model Development
时间窗: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed using the Training Cohort (March 2020 to April 2021).
Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).
次要结局
- Identification of Key Metabolites(At study inclusion (T0).)
- Validation of the Predictive Model(From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed during the Validation Cohort phase (May to October 2021).)
研究者
Andrea Castellvi
Clinical Investigator
Hospital del Mar