Multimodal Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure Under Non Invasive Ventilation Support
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- NIV FAILURE
研究概览
简要总结
NIVAR01 (Multimodal evaluation of physical capacity and energy requirements in patients with hypoxemic acute respiratory failure and community acquired pneumonia under non invasive ventilation support) aims to comprehensively assess energy requirements and physical capacity in patients with acute hypoxemic respiratory failure (AHRF) due to community-acquired pneumonia (CAP) undergoing non-invasive ventilation (NIV).
Through a stepwise, multimodal approach integrating physiological measurements, imaging, and molecular biomarkers, the project seeks to identify patient subphenotypes that can guide targeted interventions, improve outcomes, and reduce the need for invasive mechanical ventilation. The project is structured in five progressive phases, each building on the findings of the previous one to refine and personalize care strategies.
The first phase of the project aims to assess the correlation between BIA (bioelectrical impedance analysis) and IC (indirect calorimetry) in sedated patients, in oder to extrapolate this correlation in patients under NIV in the next phase.
The second phase uses this correlation to validate the use of indirect calorimetry (IC) in patients under non-invasive ventilation (NIV) by comparing it with data obtained from patients under invasive mechanical ventilation, where IC is better established and technically more accurate. This comparative approach will serve to assess the reliability and feasibility of IC in NIV settings, incorporating correction factors for air leaks and comparing with BIA data, laying the groundwork for its integration with other physiological and biochemical measurements in subsequent phases.
The third phase expands to a multimodal prospective observational cohort study integrating IC, BIA, ultrasound, biomarkers of mitochondrial and endothelial dysfunction, and innate immune system paralysis. These data will be used for patient phenotyping through advanced machine learning. The fourth and fifth phases will develop and test personalized nutritional and motor interventions (e.g., phrenic nerve stimulation, tailored physiotherapy) in clinical trials based on identified patient subtypes.
Previous studies (Georges et al., Siirala et al., Singer 2024) have demonstrated the feasibility of using IC in NIV patients, although limited by methodological constraints. This project brings novelty by incorporating BIA-derived metabolic rate estimates and segmental analysis, offering new insights into body composition, fluid balance, and muscle integrity, including diaphragm function.
Additionally, biomarkers such as cf-mtDNA, FGF-21, GDF-15, HSP60/10, and cytokine profiles (TNFα, IL-6, IL-10, CRP), as well as endothelial markers (e-Selectin, sICAM-1, vCAM-1, Syndecan-1), will be analyzed. Immune paralysis will be studied via monocyte HLA-DR expression and LPS-stimulated cytokine release.
By leveraging multimodal data integration and gender-specific analysis, NIVAR 01 aims to optimize prediction of NIV failure beyond current tools such as the HACOR index and enable individualized patient management.
详细描述
Non-invasive ventilation (NIV) is widely used in patients with acute hypoxemic respiratory failure (AHRF), particularly those with community-acquired pneumonia (CAP), as a strategy to avoid intubation and invasive mechanical ventilation. However, predicting NIV failure remains a significant clinical challenge, and the existing tools, such as the HACOR index, are limited in accuracy and do not take into account crucial aspects like energy expenditure, muscle integrity, or other patient's physiological parameters.
NIVAR01 addresses this gap through a comprehensive, stepwise research plan aimed at understanding and anticipating NIV failure by integrating metabolic, physiological, imaging, and biomolecular data. The ultimate goal is to define patient subphenotypes that enable the personalization of therapy and improve clinical outcomes.
Objectives
The main objective of NIVAR 01 is to develop and validate a multimodal strategy to predict NIV failure in patients with AHRF and CAP, enabling the design of personalized therapeutic interventions. Specifically, the project aims to:
- Validate the use of indirect calorimetry during NIV and its correlation with BIA.
- Identify physiological and molecular phenotypes associated with NIV failure.
- Develop and test targeted nutritional and functional interventions based on patient subtypes.
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
- •Moderate-to-severe Acute Hypoxemic Respiratory Failure (PaO2 /FiO2 < 200mmHg) due to respiratory infection who underwent NIV support for at least 24h.
排除标准
- •Presence of electrical implants, wounds or skin damage at the designated electrode sites or the inability to perform BIA.
- •Patients who met criteria for immediate intubation upon ICU admission were also excluded.
- •Other circumstances or clinical conditions at the discretion of the investigator that precluded the participation of the patient in the study were also considered (i.e., limitation of therapeutic effort and poor prognosis).
结局指标
主要结局
NIV FAILURE
时间窗: 1 MONTH
ENDOTRACHEAL INTUBATION OR DEATH WHILE RECEIVING NIV
次要结局
- ICU LENGHT OF STAY(Through study completion, an average of 1 year)
- HOSPITAL LENGTH OF STAY(Through study completion, an average of 1 year.)
研究者
JOSE LUIS PEREZ FERNANDEZ
PhD
Hospital Universitari de Bellvitge