Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diaphragmatic Physiology Similarity Index (DPSI)
研究概览
简要总结
Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure.
Primary Research Questions
To characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure.
To assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure.
Secondary Research Questions
Feasibility and inter-operator reproducibility of diaphragmatic speckle tracking.
Assessment of the Diaphragmatic Contraction Synchrony Index.
Evaluation of End-Diaphragmatic Residual Contraction (EDRC).
Additional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Feasibility and reproducibility：adult ICU patients
- •Methodology for diaphragmatic motion synchrony:healthy adults and adult ICU patients Between-group comparisons and flow-titration study
- •Inclusion Criteria:
- •Age ≥18 years old.
- •Clear diagnosis of respiratory failure requiring respiratory support.
- •Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
- •Voluntary participation in this study and signed informed consent. If the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. If the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form.
排除标准
- •Severe chest wall deformities or diaphragmatic paralysis.
- •End-stage disease with a predicted life expectancy of less than 24 hours.
- •Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
- •Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.
结局指标
主要结局
Diaphragmatic Physiology Similarity Index (DPSI)
时间窗: Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.
The objective of this prospective observational study is to explore the Diaphragmatic Physiology Similarity Index (DPSI), derived from speckle tracking ultrasound, in guiding the adjustment of high-flow nasal cannula (HFNC) flow settings, and to assess its application in patients with acute respiratory failure.
次要结局
- Adverse events including pneumothorax, hemodynamic instability, and other complications(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.)
- Arterial blood gas analysis (ABG analysis)(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.)
- Diaphragmatic ultrasound parameters (maximum displacement, thickening fraction, etc.)(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.)
- Adverse events including pneumothorax, hemodynamic instability, and other complications(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.)
- Arterial blood gas analysis (ABG analysis)(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.)
- Diaphragmatic Contraction Synchrony Index(After each HFNC flow adjustment: Measure contraction synchrony during each flow setting period.)
- ICC (Intraclass Correlation Coefficient)(At each ultrasound assessment, record the percentage of analyzable images. Compare measurements at the beginning and throughout the study among operators.)
- Evaluation of End-Diaphragmatic Residual Contraction (EDRC)(After each mechanical ventilation period: Measure EDRC at the end of the mechanical ventilation phase, noting the diaphragm's ability to recover.)
- Diaphragmatic Displacement Velocity and Maximum Displacement(At each flow setting change: Measure the diaphragm's displacement velocity and maximum displacement at each HFNC flow rate adjustment.)
- Diaphragmatic ultrasound parameters (maximum displacement, thickening fraction, etc.)(At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.)
研究者
Huiqing Ge
Director of Respiratory Medicine
Sir Run Run Shaw Hospital