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Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study

RecruitingNAAges 18 Years - anyAllSir Run Run Shaw Hospital
NCT06996665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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: 1. Age ≥18 years old. 2. Clear diagnosis of respiratory failure requiring respiratory support. 3. Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours. 4. 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. Exclusion Criteria: 1. Severe chest wall deformities or diaphragmatic paralysis. 2. End-stage disease with a predicted life expectancy of less than 24 hours. 3. Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations). 4. Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.
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What it tests

  • High-flow adjustment sequence
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Where

2 sites
Sir Run Run shaw Hospital Zhejiang University
Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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